Label: FEXOFENADINE HYDROCHLORIDE tablet, film coated
- NDC Code(s): 51660-998-30, 51660-998-55
- Packager: OHM LABORATORIES INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 26, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
-
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?
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 180 mg Tablet Bottle Carton
†Compare To
the active ingredient of
Allegra® AllergyNDC 51660-998-30
NDC 51660-998-55
NON-DROWSY
Fexofenadine Hydrochloride
Tablets, USP 180 mgAntihistamine
Indoor and Outdoor Allergies
ALLERGY
24 Hour
Relief of:- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Nose or Throat
ohm®
30 Tablets
DO NOT USE IF INNER SAFETY SEAL IMPRINTED WITH
"SEALED for YOUR PROTECTION" IS TORN OR MISSING -
INGREDIENTS AND APPEARANCE
FEXOFENADINE HYDROCHLORIDE
fexofenadine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51660-998 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) STARCH, CORN (UNII: O8232NY3SJ) MAGNESIUM STEARATE (UNII: 70097M6I30) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Product Characteristics Color PINK Score no score Shape OVAL Size 17mm Flavor Imprint Code 545 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51660-998-30 1 in 1 CARTON 04/29/2022 1 30 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:51660-998-55 1 in 1 CARTON 04/29/2022 2 150 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091567 04/29/2022 Labeler - OHM LABORATORIES INC. (184769029) Establishment Name Address ID/FEI Business Operations Sun Pharmaceutical Industries Limited 650445203 MANUFACTURE(51660-998)