Label: SUNMARK FEXOFENADINE HYDROCHLORIDE- fexofenadine hydrochloride tablet, film coated
- NDC Code(s): 49348-968-12, 49348-968-44, 49348-968-56, 49348-968-57
- Packager: Strategic Sourcing Services LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 21, 2021
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- Active ingredient (in each tablet)
- Purpose
- Uses
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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
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- 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
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INGREDIENTS AND APPEARANCE
SUNMARK FEXOFENADINE HYDROCHLORIDE
fexofenadine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-968 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) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color ORANGE (peach) Score no score Shape ROUND Size 12mm Flavor Imprint Code 93;7253 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49348-968-57 3 in 1 CARTON 04/14/2011 10/04/2017 1 5 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:49348-968-44 1 in 1 CARTON 04/14/2011 10/28/2018 2 30 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:49348-968-12 1 in 1 CARTON 04/14/2011 06/11/2015 3 60 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:49348-968-56 1 in 1 CARTON 04/14/2011 4 70 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076447 04/14/2011 Labeler - Strategic Sourcing Services LLC (116956644)