Label: FEXOFENADINE HCL tablet
- NDC Code(s): 21130-769-03, 21130-769-07
- Packager: Safeway, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 18, 2023
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- Official Label (Printer Friendly)
- Active Ingrdient (in each 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
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- PDP
-
INGREDIENTS AND APPEARANCE
FEXOFENADINE HCL
fexofenadine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-769 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 MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color orange (Peach) Score no score Shape OVAL (Capsule-shaped) Size 17mm Flavor Imprint Code G6 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-769-07 15 in 1 BLISTER PACK; Type 0: Not a Combination Product 11/06/2023 2 NDC:21130-769-03 30 in 1 BOTTLE; Type 0: Not a Combination Product 11/06/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211075 11/06/2023 Labeler - Safeway, Inc (009137209)