Label: CAREALL CETIRIZINE HCL- cetirizine tablet
- NDC Code(s): 51824-076-01
- Packager: New World Imports
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 7, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
Do not use if you have ever had an allergic reaction to this product or any of its ingredients or 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 sedatives or tranquilizers
When using this product drowsiness may occur. Avoid alcoholic drinks. Alcohol, sedatives and tranquilizers may increase drowsiness. Be careful when driving a motor vehicle or operating machinery.
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
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DOSAGE & ADMINISTRATION
Adult and children over 6 years old: One 10mg tablet once daily: no more than one 10mg tablet in 24 hours. A 5mg 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
- PREGNANCY
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CAREALL CETIRIZINE HCL
cetirizine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51824-076 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 LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color white (White to off white) Score 2 pieces Shape RECTANGLE (rounded off rectangular) Size 9mm Flavor Imprint Code G;4 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51824-076-01 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/02/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209274 03/02/2020 07/01/2026 Labeler - New World Imports (075372276) Registrant - New World Imports (075372276)