Label: CETIRIZINE HYDROCHLORIDE tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 12634-987-00, 12634-987-01, 12634-987-50, 12634-987-71, view more12634-987-80, 12634-987-96, 12634-987-97 - Packager: Apotheca Inc.
- This is a repackaged label.
- Source NDC Code(s): 0378-3637
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 7, 2010
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- Ask a Doctor before use
- Ask a Doctor or Pharmacist before use
- When using this product
- Stop use and ask a doctor
- If pregnant or breast-feeding:
- Keep out of reach of children.
- Directions
- Other information and inactive ingredients
- Questions
- PACKAGE LABEL AND PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:12634-987(NDC:0378-3637) 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 CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MAGNESIUM STEARATE (UNII: 70097M6I30) HYPROMELLOSE (UNII: 3NXW29V3WO) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white (WHITE) Score no score Shape BULLET (Barrel Shaped) Size 8mm Flavor Imprint Code M;C37 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:12634-987-96 6 in 1 BOTTLE, PLASTIC 2 NDC:12634-987-97 7 in 1 BOTTLE, PLASTIC 3 NDC:12634-987-00 10 in 1 BOTTLE, PLASTIC 4 NDC:12634-987-80 20 in 1 BOTTLE, PLASTIC 5 NDC:12634-987-71 30 in 1 BOTTLE, PLASTIC 6 NDC:12634-987-50 50 in 1 BOTTLE, PLASTIC 7 NDC:12634-987-01 100 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076677 01/01/2010 Labeler - Apotheca Inc. (051457844) Establishment Name Address ID/FEI Business Operations Apotheca Inc. 051457844 repack, relabel