Label: CETIRIZINE HYDROCHLORIDE tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 67668-161-00, 67668-161-30, 67668-161-45 - Packager: Unique Pharmaceutical Laboratories
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 18, 2009
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Uses
- Warnings
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- When using this product
- STOP USE
- If pregnant or breast-feeding:
- Keep out of reach of children.
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Directions
Adults and children 6
years and over
1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours. Adults 65 years and over 1 tablet1 tablet once a day; do not take more than 1 tablet in 24 hours. Children under 6 years of age Ask a doctor Consumers with liver or kidney disease Ask a doctor - Other Information
- Inactive Ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- Cetirizine Hydrochloride Tablets 5 mg Container Label
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INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67668-161 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cetirizine Hydrochloride (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24) Cetirizine Hydrochloride 5 mg Inactive Ingredients Ingredient Name Strength hypromellose (UNII: 3NXW29V3WO) lactose (UNII: J2B2A4N98G) magnesium stearate (UNII: 70097M6I30) starch, corn (UNII: O8232NY3SJ) polyethylene glycol (UNII: 3WJQ0SDW1A) povidone (UNII: FZ989GH94E) titanium dioxide (UNII: 15FIX9V2JP) Product Characteristics Color white (White) Score no score Shape BULLET (Barrel Shaped) Size 7mm Flavor Imprint Code CTN;5 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67668-161-30 30 in 1 BOTTLE 2 NDC:67668-161-45 45 in 1 BOTTLE 3 NDC:67668-161-00 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077829 10/01/2009 Labeler - Unique Pharmaceutical Laboratories (917165052) Registrant - Unique Pharmaceutical Laboratories (917165052) Establishment Name Address ID/FEI Business Operations Unique Pharmaceutical Laboratories 650434645 MANUFACTURE, analysis