Label: ALLERGY RELIEF- fexofenadine hcl tablet
- NDC Code(s): 80539-801-30
- Packager: Allwell Health Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 20, 2022
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
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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
- 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?
-
Principal Display Panel
allergy relief
fexofenadine HCI tablets USP 180 mg
antihistamine
24 hour relief of
- runny nose
- sneezing
- itchy, watery eyes
- itchy nose or throat
non-drowsy
caplets**
(**capsule-shaped tablets)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
distributed by:
AllWell Health, Inc.
Princeton, NJ 08540
getallwell.com
- Product Label
-
INGREDIENTS AND APPEARANCE
ALLERGY RELIEF
fexofenadine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80539-801 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) HYPROMELLOSES (UNII: 3NXW29V3WO) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color pink Score no score Shape CAPSULE Size 17mm Flavor Imprint Code G6 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80539-801-30 1 in 1 BOX 01/29/2021 1 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211075 01/29/2021 Labeler - Allwell Health Inc (117644800)