Allergy Active Ingredient (In Each Film-Coated Tablet)
Fexofenadine HCl USP 60 mg
Fexofenadine Hcl Tablet, Film Coated
FDA Label NDC 0904-7486
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Fexofenadine Hcl (NDC 0904-7486). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding allergy active ingredient (in each film-coated tablet), purpose, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
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
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding,
ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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).
Directions
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 |
Other Information
- store between 20° and 25°C (68° and 77°F)
- protect from excessive moisture
- each tablet contains: sodium 2.7mg(for 60 mg)
- this product meets the requirements of USP Dissolution Test 2
Inactive Ingredients
anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, pregelatinized starch(maize), stearic acid, opadry pink 03B84893 containing hypromellose, polyethylene glycol, red iron oxide titanium dioxide and yellow iron oxide.
Questions Or Comments?
Call toll-free 1-800-616-2471
Package Label.Principal Display Panel
Distributed by:
MAJOR ® PHARMACEUTICALS
Livonia, MI 48152
Package/Label Principal Display Panel
MAJOR ®
NDC 0904-7192-60
Compare to the active ingredient in Allegra ® Allergy ⋆
Non-Drowsy
Fexofenadine Hydrochloride Tablets USP
60 mg
Antihistamine
12 HR
Indoor/Outdoor Allergy Relief
• Sneezing • Runny Nose
• Itchy, Watery Eyes • Itchy Nose or Throat
100 Tablets Allergy
Sciegen Pharmaceuticals, Inc. (Fexofenadine Allergy 60)
MAJOR ®
NDC 0904-7192-40
Compare to the active ingredient in Allegra ® Allergy ⋆
Non-Drowsy
Fexofenadine Hydrochloride Tablets USP
60 mg
Antihistamine
12 HR
Indoor/Outdoor Allergy Relief
• Sneezing • Runny Nose
• Itchy, Watery Eyes • Itchy Nose or Throat
500 Tablets Allergy
Sciegen Pharmaceuticals, Inc. (Fexofenadine Allergy 40)
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