Label: ALLERGY RELIEF- fexofenadine hcl tablet
- NDC Code(s): 59726-504-03, 59726-504-12, 59726-504-30
- Packager: P & L Development, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 7, 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
-
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*
ORIGINAL PRESCRIPTION STRENGTH
allergy relief
Fexofenadine HCl 180 mg
Antihistamine
for Indoor and outdoor allergies
non-drowsy
coated caplets**
(**capsules-shaped tablets)
24 Hour Relief of:
- runny nose
- sneezing
- itchy, watery eyes
- itchy nose or throat
*This product is not manufactured or distributed by Chattem Inc., distributor of Allegra® Allergy 24 hour
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Distributed by:
PL Developments
200 Hicks Street
Westbury, NY 11590
- Product Label
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INGREDIENTS AND APPEARANCE
ALLERGY RELIEF
fexofenadine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59726-504 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) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white 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:59726-504-03 3 in 1 CARTON 03/31/2016 03/31/2025 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:59726-504-30 30 in 1 CARTON 03/31/2016 03/31/2025 2 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:59726-504-12 1 in 1 BOX 03/31/2016 03/31/2025 3 120 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 ANDA079112 03/31/2016 03/31/2025 Labeler - P & L Development, LLC (800014821)