Label: CETIRIZINE HYDROCHLORIDE tablet
- NDC Code(s): 16571-401-10
- Packager: Rising Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated May 16, 2018
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- ACTIVE INGREDIENTS (IN EACH TABLET)
DO NOT USE
Do Not Use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
WHEN USING THIS PRODUCT
- drowsines may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinary.
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
IF PREGNANT OR BREAST-FEEDING
- if breast-feeding: not recommended
- if pregnant: ask a health professional before use.
Adults and children 6years and over
1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours
Adults 65 years and over
1 tablet once a day; do not take more than 1 tablet in 24 hours
Children under 6 years of age
Ask a doctor
Consumers with liver or kidney disease
Ask a doctor
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- SPL UNCLASSIFIED SECTION
- Cetirizine Hydrochloride Tablets USP 5 mg
INGREDIENTS AND APPEARANCE
cetirizine hydrochloride tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:16571-401 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cetirizine Hydrochloride (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24) Cetirizine Hydrochloride 5 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSES (UNII: 3NXW29V3WO) lactose (UNII: J2B2A4N98G) magnesium stearate (UNII: 70097M6I30) starch, corn (UNII: O8232NY3SJ) polyethylene glycol (UNII: 3WJQ0SDW1A) povidone (UNII: FZ989GH94E) titanium dioxide (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (White) Score no score Shape BULLET (Barrel Shaped) Size 7mm Flavor Imprint Code CTN;5 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:16571-401-10 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077829 10/01/2009 Labeler - Rising Pharmaceuticals, Inc. (835513529) Registrant - Unique Pharmaceutical Laboratories (917165052) Establishment Name Address ID/FEI Business Operations Unique Pharmaceutical Laboratories 650434645 ANALYSIS(16571-401) , MANUFACTURE(16571-401)