Label: FEXOFENADINE HCL tablet
- NDC Code(s): 51316-768-06
- Packager: CVS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 18, 2024
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
- 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
ammonium hydroxide, colloidal silicon dioxide, croscarmellose sodium, D & C Red 33, ferrosoferric oxide, FD & C blue 1, FD & C yellow 6, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol,
pregelatinized starch, propylene glycol, shellac, titanium dioxide. - Questions or comments?
- PDP
-
INGREDIENTS AND APPEARANCE
FEXOFENADINE HCL
fexofenadine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51316-768 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 PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) D&C RED NO. 33 (UNII: 9DBA0SBB0L) AMMONIA (UNII: 5138Q19F1X) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GELATIN (UNII: 2G86QN327L) HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color gray ((White band in the middle)) Score no score Shape OVAL ((capsule shaped tablet)) Size 20mm Flavor Imprint Code G18 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51316-768-06 60 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211075 01/01/2024 Labeler - CVS (062312574)