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| Product NDC Code | 0904-7486 | ||||||||||
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| Drug Name | Fexofenadine hcl |
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| Type | Generic | ||||||||||
| Pharm Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||||||
| Dosage Form | TABLET, FILM COATED | ||||||||||
| RxCUI drug identifier | 997420, 997501 |
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| Application Number | ANDA204507 | ||||||||||
| Labeler Name | Major Pharmaceuticals | ||||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.ALLERGY Active ingredient (in each film-coated tablet) Fexofenadine HCl USP 60 mg Fexofenadine HCl USP 180 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Directions (for 60mg) adults and children 12 years of age and over take one 60mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor Directions (for 180mg) adults and children 12 years of age and over take one 180mg tablet with water once a day; do not take more than 1 tablet in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol, pregelatinized starch (maize), red iron oxide, stearic acid, titanium dioxide, and yellow iron oxide
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat
Purpose
Information about the drug product’s indications for use.Purpose Antihistamine
Spl product data elements
Usually a list of ingredients in a drug product.fexofenadine hcl fexofenadine hcl ANHYDROUS LACTOSE SILICON DIOXIDE STARCH, CORN CROSCARMELLOSE SODIUM LACTOSE MONOHYDRATE STEARIC ACID HYPROMELLOSE, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED FERRIC OXIDE RED TITANIUM DIOXIDE FERRIC OXIDE YELLOW FEXOFENADINE HYDROCHLORIDE FEXOFENADINE SG;201 fexofenadine hcl fexofenadine hcl ANHYDROUS LACTOSE SILICON DIOXIDE STARCH, CORN CROSCARMELLOSE SODIUM LACTOSE MONOHYDRATE STEARIC ACID HYPROMELLOSE, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED FERRIC OXIDE RED TITANIUM DIOXIDE FERRIC OXIDE YELLOW FEXOFENADINE HYDROCHLORIDE FEXOFENADINE SG;202
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Package/Label Principal Display Panel MAJOR ® NDC 0904-7192-04 Compare to the active ingredient in Allegra ® Allergy * Non-Drowsy Fexofenadine Hydrochloride Tablets, USP 60 mg Antihistamine 12-Hour Indoor/Outdoor Allergy Relief ◾ Sneezing ◾ Runny Nose ◾ Itchy, Watery Eyes ◾ Itchy Nose or Throat 100 Tablets Allergy Relief MAJOR ® NDC 0904-7192-60 Compare to the active ingredient in Allegra ® Allergy * Non-Drowsy Fexofenadine Hydrochloride Tablets, USP 60 mg Antihistamine 12-Hour Indoor/Outdoor Allergy Relief ◾ Sneezing ◾ Runny Nose ◾ Itchy, Watery Eyes ◾ Itchy Nose or Throat 100 Tablets Allergy Relief MAJOR ® NDC 0904-7192-40 Compare to the active ingredient in Allegra ® Allergy * Non-Drowsy Fexofenadine Hydrochloride Tablets, USP 60 mg Antihistamine 12-Hour Indoor/Outdoor Allergy Relief ◾ Sneezing ◾ Runny Nose ◾ Itchy, Watery Eyes ◾ Itchy Nose or Throat 500 Tablets Allergy Relief MAJOR ® NDC 0904-7486-02 Compare to the active ingredient in Allegra ® Allergy 24 Hour Tablets * Non-Drowsy Fexofenadine Hydrochloride Tablets, USP 180 mg Antihistamine 24-Hour Indoor/Outdoor Allergy Relief ◾ Sneezing ◾ Runny Nose ◾ Itchy, Watery Eyes ◾ Itchy Nose or Throat 30 Tablets Allergy Relief MAJOR ® NDC 0904-7486-03 Compare to the active ingredient in Allegra ® Allergy 24 Hour Tablets * Non-Drowsy Fexofenadine Hydrochloride Tablets, USP 180 mg Antihistamine 24-Hour Indoor/Outdoor Allergy Relief ◾ Sneezing ◾ Runny Nose ◾ Itchy, Watery Eyes ◾ Itchy Nose or Throat 30 Tablets Allergy Relief MAJOR ® NDC 0904-7486-60 Compare to the active ingredient in Allegra ® Allergy 24 Hour Tablets * Non-Drowsy Fexofenadine Hydrochloride Tablets, USP 180 mg Antihistamine 24-Hour Indoor/Outdoor Allergy Relief ◾ Sneezing ◾ Runny Nose ◾ Itchy, Watery Eyes ◾ Itchy Nose or Throat 100 Tablets Allergy Relief MAJOR ® NDC 0904-7486-40 Compare to the active ingredient in Allegra ® Allergy 24 Hour Tablets * Non-Drowsy Fexofenadine Hydrochloride Tablets, USP 180 mg Antihistamine 24-Hour Indoor/Outdoor Allergy Relief ◾ Sneezing ◾ Runny Nose ◾ Itchy, Watery Eyes ◾ Itchy Nose or Throat 500 Tablets Allergy Relief Fexofenadine-60mg-100s Fexofenadine-60mg-100s Fexofenadine-60mg-500s Fexofenadine-180mg-30s Fexofenadine-180mg-30s Fexofenadine-180mg-100s Fexofenadine-180mg-500s
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call toll-free 1-888-588-1418 Monday-Friday 9AM-7PM EST Distributed by: MAJOR ® PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471 www.majorpharmaceuticals.com
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions)
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information store between 20° and 25°C (68° and 77°F) protect from excessive moisture each tablet contains: sodium 2.7 mg (for 60 mg), sodium 8.2 mg (for 180 mg) this product meets the requirements of USP Dissolution Test 2
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions) Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API