Label: ALLERGY RELIEF- cetirizine hydrochloride tablet, film coated
- NDC Code(s): 70677-1241-1
- Packager: Strategic Sourcing Services LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 6, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each tablet) Cetirizine HCl 10 mg
- Purpose Antihistamine
- Uses● temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ● runny nose ● sneezing ● itchy, watery eyes ● itching of the nose or throat
- Warnings
- Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.
- Ask a doctor or pharmacist before use if you aretaking tranquilizers or sedatives.
- 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 ifan 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.
- Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
- Directions ● 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 store between 20° to 25°C (68° to 77°F)
- Inactive ingredients colloidal silicon dioxide**, croscarmellose sodium**, hypromellose, lactose, magnesium stearate, maize starch**, microcrystalline cellulose**, polyethylene glycol, povidone**, titanium dioxide **containes one or more of these ingrdients
- Questions or comments? 833-358-6431
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INGREDIENTS AND APPEARANCE
ALLERGY RELIEF
cetirizine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-1241 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE 10 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) MAIZE INVERT SUGAR (UNII: ED959S6ACY) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white (white to off-white) Score no score Shape BULLET (barrel shaped, biconvex) Size 8mm Flavor Imprint Code CTN;10 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70677-1241-1 120 in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077829 01/23/2024 Labeler - Strategic Sourcing Services LLC (116956644)
