Label: ALLERGY RELIEF- fexofenadine hcl tablet, coated
- NDC Code(s): 71626-502-01
- Packager: Medstone Pharma LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 1, 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?
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Principal Display Panel
*Compare to the active ingredient in Allegra® Allergy 24 Hour
Allergy Relief
Fexofenadine HCL USP 180 mg
Antihistamine
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.
Distributed by:
Medstone Pharma LLC
3300 Corporate Ave. #112
Weston, FL 33331
- Product Label
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INGREDIENTS AND APPEARANCE
ALLERGY RELIEF
fexofenadine hcl tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71626-502 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) HYPROMELLOSES (UNII: 3NXW29V3WO) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color pink Score no score Shape CAPSULE Size 18mm Flavor Imprint Code J;44 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71626-502-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/01/2019 01/31/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204097 10/01/2019 01/31/2025 Labeler - Medstone Pharma LLC (080783388)