Label: CETIRIZINE HYDROCHLORIDE tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 0904-5852-41, 0904-5852-43, 0904-5852-46, 0904-5852-60, view more0904-5852-61, 0904-5852-89 - Packager: Major Pharmaceuticals
- This is a repackaged label.
- Source NDC Code(s): 60505-2633
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 12, 2019
If you are a consumer or patient please visit this version.
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
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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 hydroxyzine.
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
When using this product
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- drowsiness may occur
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- avoid alcoholic drinks
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- alcohol, sedatives, and tranquilizers may increase drowsiness
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- 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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Directions
adults and children 6 years and over
Take 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
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-5852(NDC:60505-2633) 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) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) MAGNESIUM STEARATE (UNII: 70097M6I30) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYDEXTROSE (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score no score Shape RECTANGLE (pillow-shaped) Size 9mm Flavor Imprint Code 10MG;APO Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-5852-41 14 in 1 CARTON 12/27/2007 02/29/2020 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0904-5852-43 45 in 1 BOTTLE; Type 0: Not a Combination Product 12/27/2007 3 NDC:0904-5852-46 30 in 1 BOTTLE; Type 0: Not a Combination Product 12/27/2007 4 NDC:0904-5852-60 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/27/2007 5 NDC:0904-5852-89 90 in 1 BOTTLE; Type 0: Not a Combination Product 12/27/2007 6 NDC:0904-5852-61 100 in 1 CARTON 12/27/2007 02/29/2020 6 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078317 12/27/2007 Labeler - Major Pharmaceuticals (191427277)