Label: FEXOFENADINE HCL tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 68071-4846-9 - Packager: NuCare Pharmaceuticals,Inc.
- This is a repackaged label.
- Source NDC Code(s): 69230-300
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 17, 2021
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- WHEN USING THIS PRODUCT
- STOP USE AND ASK DOCTOR IF
- PREGNANCY/BREASTFEEDING
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- Other information
- STORAGE
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FEXOFENADINE HCL
fexofenadine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68071-4846(NDC:69230-300) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE 180 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYPROMELLOSES (UNII: 3NXW29V3WO) PARAFFIN (UNII: I9O0E3H2ZE) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) STARCH, CORN (UNII: O8232NY3SJ) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color pink Score no score Shape CAPSULE Size 18mm Flavor Imprint Code J;44 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68071-4846-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 04/15/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204097 08/19/2016 Labeler - NuCare Pharmaceuticals,Inc. (010632300) Establishment Name Address ID/FEI Business Operations NuCare Pharmaceuticals,Inc. 010632300 repack(68071-4846)