Label: CETIRIZINE HYDROCHLORIDE tablet, chewable
-
Contains inactivated NDC Code(s)
NDC Code(s): 49035-652-24, 49035-652-25 - Packager: Wal-Mart Stores, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 21, 2018
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient in each chewable tablet
- PURPOSE
- Uses
- WARNINGS
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use
- When using this product
- Stop use and ask doctor if
- If pregnant or breast-feeding
- Keep out of the reach of children
-
Directions
- may be taken with or without water
Adults and children 6 years and over
One 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
Adults 65 years and over
Ask a doctor
Children under 6 years of age
Ask a doctor
Consumers with liver or kidney disease
Ask a doctor
- OTHER INFORMATION
- Inactive Ingredients
- QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-652 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14) POLACRILIN (UNII: RCZ785HI7S) ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SUCRALOSE (UNII: 96K6UQ3ZD4) MAGNESIUM STEARATE (UNII: 70097M6I30) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Product Characteristics Color YELLOW Score no score Shape ROUND Size 10mm Flavor TUTTI FRUTTI Imprint Code n;10 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-652-24 4 in 1 CARTON 03/08/2016 1 NDC:49035-652-25 6 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 ANDA206793 03/08/2016 Labeler - Wal-Mart Stores, Inc. (051957769) Registrant - Novel Laboratories, Inc. (793518643) Establishment Name Address ID/FEI Business Operations Novel Laboratories, Inc. 793518643 ANALYSIS(49035-652) , MANUFACTURE(49035-652) , PACK(49035-652)