Label: FEXOFENADINE HCL tablet, film coated
- NDC Code(s): 0904-7192-40, 0904-7192-60
- Packager: Major Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 11, 2023
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- Official Label (Printer Friendly)
- ALLERGY Active ingredient (in each film-coated tablet)
- Purpose
- Uses
-
Warnings
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)
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
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
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
-
INGREDIENTS AND APPEARANCE
FEXOFENADINE HCL
fexofenadine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-7192 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE 60 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) STEARIC ACID (UNII: 4ELV7Z65AP) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Product Characteristics Color pink Score no score Shape OVAL Size 12mm Flavor Imprint Code SG;201 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-7192-60 100 in 1 BOTTLE; Type 0: Not a Combination Product 08/26/2021 2 NDC:0904-7192-40 500 in 1 BOTTLE; Type 0: Not a Combination Product 08/26/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204507 08/26/2021 Labeler - Major Pharmaceuticals (191427277) Registrant - ScieGen Pharmaceuticals, Inc. (079391286) Establishment Name Address ID/FEI Business Operations ScieGen Pharmaceuticals, Inc. 079391286 analysis(0904-7192) , manufacture(0904-7192) , pack(0904-7192) , label(0904-7192)