Label: FEXOFENADINE HYDROCHLORIDE- fexofenadine hcl tablet, film coated
-
Contains inactivated NDC Code(s)
NDC Code(s): 68071-3228-1, 68071-3228-2, 68071-3228-3, 68071-3228-4, view more68071-3228-9 - Packager: NuCare Pharmaceuticals, Inc.
- This is a repackaged label.
- Source NDC Code(s): 45802-425
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 22, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each 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?
- Package/Label Principal Display Panel
-
INGREDIENTS AND APPEARANCE
FEXOFENADINE HYDROCHLORIDE
fexofenadine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68071-3228(NDC:45802-425) 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSES (UNII: 3NXW29V3WO) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) Product Characteristics Color orange (Peach) Score no score Shape ROUND Size 8mm Flavor Imprint Code 93;7252 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68071-3228-1 10 in 1 BOTTLE; Type 0: Not a Combination Product 05/05/2017 2 NDC:68071-3228-4 14 in 1 BOTTLE; Type 0: Not a Combination Product 05/05/2017 3 NDC:68071-3228-2 20 in 1 BOTTLE; Type 0: Not a Combination Product 05/05/2017 4 NDC:68071-3228-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/05/2017 5 NDC:68071-3228-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/05/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076447 08/08/2011 Labeler - NuCare Pharmaceuticals, Inc. (010632300) Establishment Name Address ID/FEI Business Operations NuCare Pharmaceuticals, Inc. 010632300 repack(68071-3228)