Label: ALLERGY RELIEF- fexofenadine hydrochloride tablet
- NDC Code(s): 57344-192-02, 57344-192-04, 57344-192-06
- Packager: AAA Pharmaceutical, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 5, 2021
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
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WARNINGS
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
RESTORE U
NDC 57344-192-02
COMPARE TO THE ACTIVE INGREDIENT IN ALLEGRA® ALLERGY 24 HOUR
NON-DROWSY
Allergy Relief
Fexofenadine Hydrochloride Tablets, 180 mg / Antihistamine
Indoor and Outdoor Allergies – Original Prescription Strength
Relieves: Sneezing, Runny Nose, Itchy, Watery Eyes, Itchy Nose or Throat
24 HR
Actual Size
5 TABLETS
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INGREDIENTS AND APPEARANCE
ALLERGY RELIEF
fexofenadine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57344-192 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 ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) STEARIC ACID (UNII: 4ELV7Z65AP) FERRIC OXIDE RED (UNII: 1K09F3G675) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Product Characteristics Color pink Score no score Shape OVAL (Modified oval shape) Size 17mm Flavor Imprint Code SG;202 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57344-192-02 1 in 1 CARTON 10/01/2018 10/31/2022 1 5 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:57344-192-04 1 in 1 CARTON 06/01/2018 05/31/2021 2 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:57344-192-06 1 in 1 CARTON 06/01/2018 02/28/2023 3 45 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 06/01/2018 02/28/2023 Labeler - AAA Pharmaceutical, Inc. (181192162)