Label: ALLERGY RELIEF- fexofenadine hcl tablet
- NDC Code(s): 55319-965-15, 55319-965-30
- Packager: Family Dollar (FAMILY WELLNESS)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 14, 2023
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- 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
COMPARE TO THE ACTIVE INGREDIENT IN ALLEGRA® ALLERGY 24 HOUR*
ALLERGY RELIEF
Fexofenadine HCl Tablets USP, 180 mg
Antihistamine
24 HOUR RELIEF OF
- Runny nose
- Sneezing
- Itchy, watery eyes
- Itchy nose or throat
For indoor and outdoor allergies
Non-drowsy
CAPLETS**
(**CAPSULE-SHAPED TABLETS)
*This product is not manufactured or distributed by Chattem Inc., distributor of Allegra® Allergy 24 Hour.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY
MIDWOOD BRANDS, LLC
500 VOLVO PARKWAY
CHESAPEAKE, VA 23320
- Product Label
-
INGREDIENTS AND APPEARANCE
ALLERGY RELIEF
fexofenadine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-965 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) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERROSOFERRIC OXIDE (UNII: XM0M87F357) STARCH, CORN (UNII: O8232NY3SJ) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white Score no score Shape OVAL Size 17mm Flavor Imprint Code G6 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-965-30 1 in 1 BOX 07/01/2023 1 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:55319-965-15 15 in 1 CARTON 07/01/2023 2 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211075 07/01/2023 Labeler - Family Dollar (FAMILY WELLNESS) (024472631)