Label: CETIRIZINE HYDROCHLORIDE 10 MG- cetirizine hydrochloride tablet
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- NDC Code(s): 73581-202-01, 73581-202-05
- Packager: YYBA CORP
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 11, 2023
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- Active ingredient (in each tablet)
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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 to an antihistamine containing hydroxyine.
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:
- 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.
If pregnant or breast-feeding:
- if breast-feeding: not recommended
- if pregnant: ask a health professional before use
- KEEP OUT OF REACH OF CHILDREN
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Directions
adults and children 6 years and over take one 10 mg tablet oncedaily; do not take more than one 10mg tablet in 24 hours. A 5mg product may be appropriate for less severe symptoms. adults 65 years and older ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor - Other information
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INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROCHLORIDE 10 MG
cetirizine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73581-202 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 2208 (100 MPA.S) (UNII: B1QE5P712K) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score 2 pieces Shape RECTANGLE Size 10mm Flavor Imprint Code G4 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73581-202-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/16/2021 2 NDC:73581-202-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 06/17/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209274 06/16/2021 Labeler - YYBA CORP (006339772)
