Niften may be available in the countries listed below.
Atenolol is reported as an ingredient of Niften in the following countries:
Nifedipine is reported as an ingredient of Niften in the following countries:
International Drug Name Search
Ferrex™ 150 Forte Capsules are a highly water soluble complex of iron/low molecular weight polysaccharide and vitamins.
Each Ferrex™ 150 Forte Capsule contains:
| Elemental Iron (as Polysaccharide Iron) | 150 mg |
| Folic Acid | 1 mg |
| Vitamin B12 (Cyanocobalamin) | 25 mcg |
Inactive Ingredients: Citric Acid, Croscarmellose Sodium, Dicalcium Phosphate, FD&C Blue No.1 Lake, FD&C Red No. 40 Lake, Gelatin, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinylpyrrolidone, Sodium Lauryl Sulfate, Stearic Acid and Titanium Dioxide.
Usual adult dosage is 1 capsule daily, or as directed by a physician.
Ferrex™ 150 Forte is indicated for the dietary management of iron deficiency anemia and/or nutritional megaloblastic anemias.
Ferrex™ 150 Forte is contraindicated in patients with a known hypersensitivity to any of the components of this product. Hemochromatosis and hemosiderosis are contraindications to iron supplementation.
Folic Acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
Do not exceed recommended dose.
The type of anemia and the underlying cause or causes should be determined before starting Ferrex™ 150 Forte. Since the anemia may be a result of a systemic disturbance, such as recurrent blood loss, the underlying cause or causes should be corrected, if possible.
Folic Acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anemia should be excluded before using this product since folic acid may mask the symptoms of pernicious anemia.
Safety and effectiveness in pediatric patients have not been established.
Clinical studies on this product have not been performed in subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Adverse reactions with iron supplementation may include constipation, diarrhea, nausea, vomiting, dark stools and abdominal pain. Adverse reactions with iron therapy are usually transient.
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
The clinical course of acute iron overdosage can be variable. Initial symptoms may include abdominal pain, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, hypotension, tachycardia, metabolic acidosis, hyperglycemia, dehydration, drowsiness, pallor, cyanosis, lassitude, seizures, shock and coma.
Ferrex™ 150 Forte capsules are available as an opaque maroon capsule, imprinted B 198. Supplied in Unit Dose blister packs, 10 capsules per card, NDC 51991-198-11.
Warning: Keep this and all medications out of the reach of children.
If pregnant, or planning to become pregnant or are currently breast-feeding please contact your physician, or health-care provider before using or continuing use.
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature.
Protect from light and moisture.
All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.
Rx Only
Manufactured by:
Contract Pharmacal Corp.
Hauppauge, NY 11788 USA
www.cpc.com
Rev. 08/09
Distributed by:
Breckenridge Pharmaceutical, Inc.
Boca Raton, FL 33487
Breckenridge
Pharmaceutical, Inc.
NDC 51991-198-11
Ferrex™ 150
Forte
Capsules
Rx Only
100 CAPSULES
(10 x 10) Unit Dose
| FERREX 150 FORTE iron, folic acid, and cyanocobalamin capsule | ||||||||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| UNAPPROVED DRUG OTHER | 04/01/2001 | 05/30/2012 | |
| Labeler - Breckenridge Pharmaceutical, Inc. (150554335) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Contract Pharmacal Corp. | 057795122 | MANUFACTURE | |
Tairal may be available in the countries listed below.
Famotidine is reported as an ingredient of Tairal in the following countries:
International Drug Name Search
Generic Name: acetaminophen and dextromethorphan (a SEET a MIN oh fen and DEX troe me THOR fan)
Brand Names: Children's Triacting, Triaminic Cough & Sore Throat Softchews, Tylenol Cough and Sore Throat Daytime
Acetaminophen is a pain reliever and fever reducer.
Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.
The combination of acetaminophen and dextromethorphan is used to treat cough and pain or fever caused by the common cold or flu.
Acetaminophen and dextromethorphan may also be used for other purposes not listed in this medication guide.
Ask a doctor or pharmacist about taking this medication if you have:
liver disease;
alcoholism or cirrhosis of the liver; or
emphysema or chronic bronchitis.
Artificially-sweetened liquid forms of cough medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.
Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cough medicine is usually taken only for a short time until your symptoms clear up.
Measure the liquid form of this medication with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cough medicine within the past few days.
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.
The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.
Overdose symptoms may also include dizziness, drowsiness, feeling restless or nervous, diarrhea, loss of appetite, seizure (convulsions), or coma.
Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with cough medicine can increase your risk of unpleasant side effects.
severe dizziness, anxiety, restless feeling, or nervousness;
confusion, hallucinations;
slow, shallow breathing;
easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
mild loss of appetite, upset stomach.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Before taking this medication, tell your doctor if you are using any of the following drugs:
celecoxib (Celebrex);
cinacalcet (Sensipar);
darifenacin (Enablex);
imatinib (Gleevec);
isoniazid;
quinidine (Quinaglute, Quinidex);
ranolazine (Ranexa);
ritonavir (Norvir);
sibutramine (Meridia);
terbinafine (Lamisil);
zidovudine (Retrovir, AZT);
gout medication such as probenecid (Benemid);
medicines to treat high blood pressure;
seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton); or
an antidepressant such as amitriptyline (Elavil, Etrafon), bupropion (Wellbutrin, Zyban), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), paroxetine (Paxil), sertraline (Zoloft), and others.
This list is not complete and there may be other drugs that can interact with acetaminophen and dextromethorphan. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
Indogesic may be available in the countries listed below.
Indometacin is reported as an ingredient of Indogesic in the following countries:
International Drug Name Search
Inalpin may be available in the countries listed below.
Codeine phosphate hemihydrate (a derivative of Codeine) is reported as an ingredient of Inalpin in the following countries:
Guaifenesin is reported as an ingredient of Inalpin in the following countries:
International Drug Name Search
Efavir may be available in the countries listed below.
Efavirenz is reported as an ingredient of Efavir in the following countries:
International Drug Name Search
Some patients who received high doses of Fludarabine to treat acute leukemia developed severe nervous system side effects, including blindness, coma, and death. Similar nervous system side effects, including coma, seizures, agitation, and confusion, have occurred in patients at doses recommended for the treatment of chronic lymphocytic leukemia. Discuss any questions or concerns with your doctor. Contact your doctor right away if any of these effects occur.
Fludarabine may severely decrease bone marrow function. This can lower your body's ability to fight infection and reduce the ability of your blood to clot properly. Some patients have developed severe and sometimes fatal blood problems (eg, hemolytic anemia, autoimmune thrombocytopenia, hemophilia) while using Fludarabine. Your doctor will need to monitor you closely for these conditions. Tell your doctor right away if you develop signs or symptoms of an infection (eg, swollen glands, sore throat, fever, chills), bleeding problems (eg, easy bruising; black, tarry stools; bleeding from the gums), or hemolytic anemia (eg, yellowing of eyes or skin, dark urine, severe tiredness or weakness). Be sure to keep all doctor and laboratory appointments.
Fatal lung problems have been reported in patients receiving Fludarabine along with pentostatin. Fludarabine is not recommended for use with pentostatin.
Treating patients with certain types of leukemia who have not responded to other therapy or whose disease has progressed during treatment with other medicines. It may also be used for other conditions as determined by your doctor.
Fludarabine is an antimetabolite. It works by preventing the cancer cell from reproducing, which results in death of the cell.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Fludarabine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Fludarabine. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Fludarabine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Fludarabine as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Fludarabine.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Diarrhea; general body discomfort; increased sweating; loss of appetite; muscle pain; nausea; sinus inflammation; stuffy nose; tiredness; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thinking; black, tarry, or bloody stools; blood in the urine; changes in strength or the way you walk; chest pain; confusion; coughing or vomiting blood; dark urine; difficult or painful urination; fainting; hearing loss; irregular heartbeat; lower back or side pain; mental or mood changes (eg, agitation, confusion); muscle weakness or cramps; numbness or tingling in the hands or feet; red, swollen, blistered, or peeling skin; seizures; severe or persistent tiredness or weakness; shortness of breath; signs of infection (eg, fever, chills, cough, or sore throat); skin changes; sores on the mouth or lips; swelling of the fingers, hands, or feet; unusual bruising or bleeding; vision changes or blindness; vomit that looks like coffee grounds; yellowing of the eyes or skin.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Fludarabine side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bleeding; blindness; coma; infection.
Store Fludarabine at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Fludarabine out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Fludarabine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Diprospan Inyectable may be available in the countries listed below.
Betamethasone 17α,21-dipropionate and 21-(disodium phosphate) (a derivative of Betamethasone) is reported as an ingredient of Diprospan Inyectable in the following countries:
International Drug Name Search
Calcio Cloruro Salf may be available in the countries listed below.
Calcium Chloride dihydrate (a derivative of Calcium Chloride) is reported as an ingredient of Calcio Cloruro Salf in the following countries:
International Drug Name Search
Metile Salicilato Nova Argentia may be available in the countries listed below.
Methyl Salicylate is reported as an ingredient of Metile Salicilato Nova Argentia in the following countries:
International Drug Name Search
Busyarlu may be available in the countries listed below.
Bezafibrate is reported as an ingredient of Busyarlu in the following countries:
International Drug Name Search
Nifecor may be available in the countries listed below.
Nifedipine is reported as an ingredient of Nifecor in the following countries:
International Drug Name Search
For External Use Only. Not For Ophthalmic Use.
Rx only
Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are intended for topical administration. The active component in each is the corticosteroid Fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy) -6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6a,11b,16a)-. It has the following chemical structure:
Fluocinonide Cream USP, 0.05% contains Fluocinonide 0.5 mg/g in a specially formulated cream base consisting of citric acid, glycerin, 1,2,6-hexanetriol, polyethylene glycol-3350, polyethylene glycol-8000, propylene glycol and stearyl alcohol. This white cream vehicle is greaseless, non-staining, anhydrous and completely water miscible. The base provides emollient and hydrophylic properties.
Fluocinonide Cream USP, 0.05% (Emulsified Base) contains Fluocinonide 0.5 mg/g in a water-washable aqueous emollient base of cetyl alcohol, citric acid (anhydrous), mineral oil, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, stearyl alcohol and white petrolatum.
Fluocinonide Gel USP, 0.05% contains Fluocinonide 0.5 mg/g in a specially formulated gel base consisting of carbomer 940, edetate disodium, propyl gallate, propylene glycol, sodium hydroxide (to adjust pH) and purified water. This clear, colorless, thixotropic vehicle is greaseless, non-staining and completely water miscible.
Fluocinonide Ointment USP, 0.05% contains Fluocinonide 0.5 mg/g in a specially formulated ointment base consisting of glyceryl monostearate, propylene carbonate, propylene glycol, white petrolatum and white wax. It provides the occlusive and emollient effects desirable in an ointment.
In the Fluocinonide Cream USP, 0.05%, Fluocinonide Gel USP, 0.05%, and Fluocinonide Ointment USP, 0.05% formulations, the active ingredient is totally in solution.
Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions.
The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.
Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (see DOSAGE AND ADMINISTRATION). Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.
Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.
Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.
Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.
Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS - Pediatric Use). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.
As with any topical corticosteroid product, prolonged use may produce atrophy of the skin and subcutaneous tissues. When used on intertriginous or flexor areas, or on the face, this may occur even with short-term use.
In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.
Patients using topical corticosteroids should receive the following information and instructions:
The following tests may be helpful in evaluating the HPA axis suppression:
Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.
Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.
Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.
Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.
HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.
The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:
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Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).
Fluocinonide Cream USP, 0.05%, Fluocinonide Cream USP, 0.05% (Emulsified Base), Fluocinonide Gel USP, 0.05% and Fluocinonide Ointment USP, 0.05% are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.
Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.
If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
Fluocinonide Cream USP, 0.05% is supplied in 15 g (NDC 51672-1253-1), 30 g (NDC 51672-1253-2), 60 g (NDC 51672-1253-3) and 120 g (NDC 51672-1253-4) tubes.
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
Fluocinonide Cream USP, 0.05% (Emulsified Base) is supplied in 15 g (NDC 51672-1254-1), 30 g (NDC 51672-1254-2) and 60 g (NDC 51672-1254-3) tubes.
Store at controlled room temperature. Avoid excessive heat, above 40°C (104°F).
Fluocinonide Gel USP, 0.05% is supplied in 15 g (NDC 51672-1279-1), 30 g (NDC 51672-1279-2) and 60 g (NDC 51672-1279-3) tubes.
Store at 20°- 25°C (68°- 77°F) [see USP Controlled Room Temperature].
Fluocinonide Ointment USP, 0.05% is supplied in 15 g (NDC 51672-1264-1), 30 g (NDC 51672-1264-2) and 60 g (NDC 51672-1264-3) tubes.
Store at 20°-25°C (68°-77°F). Avoid temperature above 30°C (86°F).
Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1
Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532
Revised: April, 2010
PK-4964-2
99
NDC 51672-1253-2
Fluocinonide
Cream USP, 0.05%
FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.
Keep this and all medications out of the reach of children.
30 g
Rx only
TARO
NDC 51672-1254-1
Fluocinonide
Cream USP, 0.05% (Emulsified Base)
FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.
Keep this and all medications out of the reach of children.
15 g
Rx only
TARO
NDC 51672-1279-1
Fluocinonide
Gel USP, 0.05%
FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.
Keep this and all medications out of the reach of children.
15 g
Rx only
TARO
NDC 51672-1264-1
Fluocinonide
Ointment USP, 0.05%
FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.
Keep this and all medications out of the reach of children.
15 g
Rx only
TARO
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA019117 | 06/26/1984 | |
| Fluocinonide Fluocinonide cream | ||||||||||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA072494 | 01/19/1989 | |
| Fluocinonide Fluocinonide gel | ||||||||||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA074935 | 07/29/1997 | |
| Fluocinonide Fluocinonide ointment | ||||||||||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA075008 | 06/30/1999 | |
| Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Taro Pharmaceuticals Inc. | 206263295 | MANUFACTURE | |
Dietary management of osteoarthritis and associated swelling. It may also be used for other conditions as determined by your doctor.
Flavocoxid/Citrated Zinc Bisglycinate is a medical food. It works by reducing swelling and providing pain relief.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Flavocoxid/Citrated Zinc Bisglycinate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Flavocoxid/Citrated Zinc Bisglycinate. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Flavocoxid/Citrated Zinc Bisglycinate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Flavocoxid/Citrated Zinc Bisglycinate as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Flavocoxid/Citrated Zinc Bisglycinate.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Diarrhea; gas; nausea.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Store Flavocoxid/Citrated Zinc Bisglycinate at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly sealed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Flavocoxid/Citrated Zinc Bisglycinate out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Flavocoxid/Citrated Zinc Bisglycinate. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Accidental overdose of products that contain iron is a leading cause of fatal poisoning in children younger than 6 years old. Keep this and all medicines out of the reach of children. In case of accidental ingestion, call the poison control center or a doctor at once.
Preventing and treating certain types of anemia (eg, caused by low blood iron levels, poor nutrition). It may also be used for other conditions as determined by your doctor.
Ferrex 150 Forte is a vitamin, folic acid, and iron combination. It works by providing vitamins, folic acid, and iron to the body.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Ferrex 150 Forte. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Ferrex 150 Forte. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Ferrex 150 Forte may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Ferrex 150 Forte as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Ferrex 150 Forte.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation; dark or green stools; diarrhea; nausea; stomach pain; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; severe or persistent nausea, vomiting, or stomach pain.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Ferrex50 Forte side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include black, tarry, or bloody stools; blue or unusually pale skin; drowsiness or dizziness; fast heartbeat; increased thirst or urination; seizures; severe or persistent nausea, vomiting, diarrhea, or stomach pain; sluggishness; vomiting blood; weakness.
Store Ferrex 150 Forte at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ferrex 150 Forte out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Ferrex 150 Forte. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
