Label: CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet, film coated
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NDC Code(s):
55111-351-04,
55111-351-30,
55111-351-45,
55111-351-47, view more55111-351-51, 55111-351-60, 55111-351-74, 55111-351-90, 55111-699-04, 55111-699-15, 55111-699-19, 55111-699-30, 55111-699-31, 55111-699-45, 55111-699-47, 55111-699-51, 55111-699-52, 55111-699-60, 55111-699-73, 55111-699-74, 55111-699-90
- Packager: Dr.Reddy's Laboratories Limited
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 30, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
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
- 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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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
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55111-699 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 HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score no score Shape OVAL Size 7mm Flavor Imprint Code C Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55111-699-90 1 in 1 CARTON 04/08/2008 1 90 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:55111-699-45 1 in 1 CARTON 04/08/2008 2 45 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:55111-699-30 1 in 1 CARTON 04/03/2008 3 30 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:55111-699-51 1 in 1 CARTON 07/22/2008 4 75 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:55111-699-04 1 in 1 CARTON 04/11/2008 5 120 in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:55111-699-19 1 in 1 CARTON 01/15/2008 6 175 in 1 BOTTLE; Type 0: Not a Combination Product 7 NDC:55111-699-47 2 in 1 CARTON 04/03/2008 7 175 in 1 BOTTLE; Type 0: Not a Combination Product 8 NDC:55111-699-60 1 in 1 CARTON 04/07/2008 8 60 in 1 BOTTLE; Type 0: Not a Combination Product 9 NDC:55111-699-73 1 in 1 CARTON 10/06/2010 9 365 in 1 BOTTLE; Type 0: Not a Combination Product 10 NDC:55111-699-52 1 in 1 CARTON 10/06/2010 10 14 in 1 BOTTLE; Type 0: Not a Combination Product 11 NDC:55111-699-74 2 in 1 CARTON 04/04/2008 11 7 in 1 BLISTER PACK; Type 0: Not a Combination Product 12 NDC:55111-699-31 1 in 1 CARTON 09/27/2016 12 300 in 1 BOTTLE; Type 0: Not a Combination Product 13 NDC:55111-699-15 1 in 1 CARTON 04/04/2008 13 14 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 ANDA078343 01/15/2008 CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55111-351 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 HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score no score Shape ROUND Size 6mm Flavor Imprint Code RDY;351 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55111-351-30 1 in 1 CARTON 01/15/2008 1 30 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:55111-351-45 1 in 1 CARTON 01/15/2008 2 45 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:55111-351-60 1 in 1 CARTON 01/15/2008 3 60 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:55111-351-90 1 in 1 CARTON 01/15/2008 4 90 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:55111-351-04 1 in 1 CARTON 01/15/2008 5 120 in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:55111-351-47 2 in 1 CARTON 01/15/2008 6 175 in 1 BOTTLE; Type 0: Not a Combination Product 7 NDC:55111-351-51 1 in 1 CARTON 01/15/2008 7 75 in 1 BOTTLE; Type 0: Not a Combination Product 8 NDC:55111-351-74 2 in 1 CARTON 01/15/2008 8 7 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 ANDA078343 01/15/2008 Labeler - Dr.Reddy's Laboratories Limited (650562841)