Label: FEXOFENADINE HCL tablet, film coated
- NDC Code(s): 63187-921-20, 63187-921-30, 63187-921-60, 63187-921-90
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 69230-202
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 1, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ALLERGY Active ingredient (in each film-coated 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?
- Compare to the active ingredient in Allegra® Allergy 24 Hour TabletsAllergy Relief - 24 HOURFEXOFENADINE HYDROCHLORIDE TABLETS USP, 180 mgAntihistamineIndoor & Outdoor Allergies
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INGREDIENTS AND APPEARANCE
FEXOFENADINE HCL
fexofenadine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63187-921(NDC:69230-202) 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) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) STEARIC ACID (UNII: 4ELV7Z65AP) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Product Characteristics Color pink Score no score Shape CAPSULE Size 17mm Flavor Imprint Code SG;202 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63187-921-20 20 in 1 BOTTLE; Type 0: Not a Combination Product 10/02/2017 2 NDC:63187-921-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 10/02/2017 3 NDC:63187-921-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 10/02/2017 4 NDC:63187-921-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 10/02/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204507 09/16/2015 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 REPACK(63187-921) , RELABEL(63187-921)