NDC | 53187-189-30 |
Set ID | 9c83780f-08c0-459e-98f7-147762eb4c21 |
Category | HUMAN OTC DRUG LABEL |
Packager | LIVE BETTER (The Great Atlantic & Pacific Tea Company) |
Generic Name | |
Product Class | |
Product Number | |
Application Number | ANDA079112 |
- 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?
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Package/Label Principal Display Panel
*Compare to the active ingredient in Allegra® Allergy 24 hour
ORIGINAL PRESCRIPTION STRENGTH
24 HOUR ALLERGY
Fexofenadine HCl tablets, USP
Indoor and outdoor allergies
180 mg/ Antihistamine
24 Hour Relief of:
- sneezing
- runny nose
- 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.
SAFETY SEALED: DO NOT USE IF CARTON IS OPEN OR IF INNER SEAL IMPRINTED WITH "SEALED FOR YOUR PROTECTION" IS MISSING OR TORN
- Product Label
-
INGREDIENTS AND APPEARANCE
24 HOUR ALLERGY
fexofenadine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53187-189 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) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POVIDONE K30 (UNII: U725QWY32X) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (light peach) Score no score Shape CAPSULE Size 17mm Flavor Imprint Code W987 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53187-189-30 1 in 1 BOX 1 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079112 03/20/2013 Labeler - LIVE BETTER (The Great Atlantic & Pacific Tea Company) (001367366) Registrant - P and L Development of New York Corporation (800014821)