Label: ALLERGY RELIEF- fexofenadine hcl tablet, coated
- NDC Code(s): 63548-0663-5
- Packager: PLD Acquisitions LLC DBA Avéma Pharma Solutions
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 9, 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 12 hour
Allergy Relief
Fexofenadine HCL USP 180 mg
Antihistamine
12 HOUR RELIEF OF:
- Sneezing
- Runny Nose
- Itchy, Water Eyes
- Itchy Throat or Nose
Caplets**
(**Capsule-shaped Tablets)
*This product is not manufactured or distributed by Chattem, Inc., distributor of Allegra® Allergy 12 hour.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN MISSING.
- Product Label
-
INGREDIENTS AND APPEARANCE
ALLERGY RELIEF
fexofenadine hcl tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63548-0663 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE 60 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYPROMELLOSES (UNII: 3NXW29V3WO) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYSORBATE 80 (UNII: 6OZP39ZG8H) STARCH, CORN (UNII: O8232NY3SJ) LIGHT MINERAL OIL (UNII: N6K5787QVP) TALC (UNII: 7SEV7J4R1U) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) Product Characteristics Color pink Score no score Shape CAPSULE Size 12mm Flavor Imprint Code J;43 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63548-0663-5 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204097 10/01/2019 Labeler - PLD Acquisitions LLC DBA Avéma Pharma Solutions (804087794)