Label: CETIRIZINE HYDROCHLORIDE tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 57451-5067-1 - Packager: Ipca Laboratories Limited
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 25, 2011
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- SPL UNCLASSIFIED SECTION
- Active Ingredient ( in each tablet)
- Purpose
- Uses
- Warnings
- Do not use
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- When using this product
- Stop use and ask a doctor if
- If pregnant or breat-feeding
- Keep out of reach of children
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Directions
adults and children 6 yearsand 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
- SPL UNCLASSIFIED SECTION
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Ohm Laboratories Inc.\Ranbaxy Group Company
NDC: 57451-5067-1
Cetirizine Hydrochloride Tablets 10 mg
1x 10000 Tablets
Each tablet contains:
Cetirizine hydrochloride 10 mg
Store between 20° to 25°C (68° to 77°F)
Code : MP/DRUGS/25/1/2008
Batch No. :
Mfg. Dt. :
Exp. Dt. :
Manufactured for:
Ohm Laboratories Inc.
14 Terminal Road
New Brunswick, NJ 08901
Manufactured by:
Ipca Laboratories Limited
1, Pharma Zone, SEZ, Indore
Pithampur- 454775 (M.P.), India
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INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57451-5067 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 POVIDONE K30 (UNII: U725QWY32X) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) STARCH, CORN (UNII: O8232NY3SJ) MAGNESIUM STEARATE (UNII: 70097M6I30) HYPROMELLOSES (UNII: 3NXW29V3WO) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color WHITE Score no score Shape ROUND (rectangular) Size 9mm Flavor Imprint Code RI52 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57451-5067-1 10000 in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077498 12/27/2007 Labeler - Ipca Laboratories Limited (862179827) Registrant - Ipca Laboratories Limited (650387009) Establishment Name Address ID/FEI Business Operations Ipca Laboratories Limited 677600550 Manufacture