Label: CETIRIZINE HYDROCHLORIDE 10 MG- cetirizine hydrochloride tablet
- NDC Code(s): 66424-564-01, 66424-564-05
- Packager: SDA Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 11, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USE
-
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 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
- 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
-
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
diseaseask a doctor - OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROCHLORIDE 10 MG
cetirizine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66424-564 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 MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score 2 pieces Shape RECTANGLE (ROUNDED-OFF RECTANGLE) Size 10mm Flavor Imprint Code G4 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66424-564-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2021 2 NDC:66424-564-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/27/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209274 04/27/2021 Labeler - SDA Laboratories, Inc. (948067889)
