Label: FEXOFENADINE HYDROCHLORIDE tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 53943-021-09, 53943-021-17, 53943-021-60, 53943-021-85 - Packager: Discount Drug Mart
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 10, 2019
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
- Warnings
- Do not use
- Ask a doctor before use if you have
- When using this product
- Stop use and ask doctor if
- If pregnant or breast-feeding
- Keep out of reach of children
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-180mg ( 30 Tablets Bottle)
NDC 53943-021-09
Original Prescription Strength
Non-Drowsy
Fexofenadine Hydrochloride Tablets USP, 180 mg/antihistamine
Allergy
24 Hours Relief of:
Sneezing
Runny nose
Itchy, watery eyes
Itchy nose or throat
Indoor & Outdoor Allergies
DO NOT USE IF FOIL SEAL IS TORN OR MISSING
30 Tablets 180 mg each
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PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-180mg ( 45 Tablets Bottle)
NDC 53943-021-17
Original Prescription Strength
Non-Drowsy
Fexofenadine Hydrochloride Tablets USP, 180 mg/antihistamine
Allergy
24 Hours Relief of:
Sneezing
Runny nose
Itchy, watery eyes
Itchy nose or throat
Indoor & Outdoor Allergies
DO NOT USE IF FOIL SEAL IS TORN OR MISSING
45 Tablets 180 mg each
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PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-180mg (15Tablets Blister)
NDC 53943-021-85
Original Prescription Strength
Non-Drowsy
Fexofenadine Hydrochloride Tablets USP, 180 mg/antihistamine
Allergy
24 Hours Relief of:
Sneezing
Runny nose
Itchy, watery eyes
Itchy nose or throat
Indoor & Outdoor Allergies
DO NOT USE IF FOIL SEAL IS TORN OR MISSING
15 Tablets 180 mg each
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INGREDIENTS AND APPEARANCE
FEXOFENADINE HYDROCHLORIDE
fexofenadine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53943-021 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) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color ORANGE (Peach) Score no score Shape CAPSULE (Bevel Edge, Biconvex) Size 17mm Flavor Imprint Code E;44 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53943-021-09 1 in 1 CARTON 05/06/2015 1 30 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:53943-021-17 1 in 1 CARTON 05/06/2015 2 45 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:53943-021-85 3 in 1 CARTON 05/06/2015 3 NDC:53943-021-60 5 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA202039 05/06/2015 Labeler - Discount Drug Mart (047741335) Establishment Name Address ID/FEI Business Operations Aurolife Pharma, LLC 829084461 MANUFACTURE(53943-021)