Label: ALLERGY RELIEF- fexofenadine hcl tablet, coated
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NDC Code(s):
59726-801-03,
59726-801-12,
59726-801-15,
59726-801-30, view more59726-801-70
- Packager: P & L Development, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 16, 2023
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?
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Principal Display Panel
Compare to the active ingredient in Allegra® Allergy 24 Hour*
allergy relief
fexofenadine HCl tablets USP, 180 mg
antihistamine
for indoor and outdoor allergies
non-drowsy
24 hour relief of
- runny nose
- sneezing,
- itchy, watery eyes
- itchy nose or throat
- for indoor & 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 PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by: PL Developments
200 Hicks Street, Westbury, NY 11590
- Product Label
-
INGREDIENTS AND APPEARANCE
ALLERGY RELIEF
fexofenadine hcl tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59726-801 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) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERROSOFERRIC OXIDE (UNII: XM0M87F357) STARCH, CORN (UNII: O8232NY3SJ) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color pink (Peach) 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:59726-801-03 3 in 1 CARTON 08/20/2021 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:59726-801-12 120 in 1 CARTON 08/20/2021 2 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:59726-801-15 15 in 1 CARTON 08/20/2021 3 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:59726-801-70 1 in 1 BOX 08/20/2021 4 70 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 5 NDC:59726-801-30 1 in 1 BOX 08/20/2021 5 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 ANDA204507 08/20/2021 Labeler - P & L Development, LLC (800014821)