Label: FEXOFENADINE HYDROCHLORIDE- fexofenadine hcl tablet
- NDC Code(s): 70934-629-30, 70934-629-90
- Packager: Denton Pharma, Inc. DBA Northwind Pharmaceuticals
- This is a repackaged label.
- Source NDC Code(s): 0904-7050
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 1, 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 film-coated 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?
-
Principal Display Panel
COMPARE TO the active ingredient in ALLEGRA® ALLERGY 24 HOUR*
FEXOFENADINE HYDROCHLORIDE USP 180 mg
Antihistamine
ALLERGY RELIEF
24-HOUR Relief of:
- sneezing
- Runny nose
- Itchy, watery eyes
- Itchy nose or throat
Indoor and Outdoor
Allergy Relief
Non-Drowsy
Capsule Shaped Tablets
*This product is not manufactured or distributed by Chattem Inc., distributor of Allegra® Allergy 24 hour
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Distributed by:
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
- Product Label
-
INGREDIENTS AND APPEARANCE
FEXOFENADINE HYDROCHLORIDE
fexofenadine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70934-629(NDC:0904-7050) 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSES (UNII: 3NXW29V3WO) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) STARCH, CORN (UNII: O8232NY3SJ) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 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:70934-629-90 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/18/2022 03/31/2025 2 NDC:70934-629-30 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/11/2022 01/31/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204507 08/11/2022 03/31/2025 Labeler - Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546) Registrant - Denton Pharma, Inc. DBA Northwind Pharmaceuticals (080355546) Establishment Name Address ID/FEI Business Operations Denton Pharma, Inc. DBA Northwind Pharmaceuticals 080355546 repack(70934-629)