Label: APTRIZINE 24-HOUR ALL DAY ALLERGY- cetirizine hydrochloride tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 46084-012-11, 46084-012-12, 46084-012-13, 46084-012-14, view more46084-012-15 - Packager: A P J Laboratories Limited
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 21, 2013
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- Official Label (Printer Friendly)
- active ingredient
- Purpose
- Keep out of reach of children
- Indications and Usage
- Warning
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Dosage and Administration
Adults and children 6years andover 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 65years and over: ask a doctor.
Children under 4-6 years of age: ask a doctor
Children under 4 years of age: ask a doctor
Consumers with liver or kidney disease: ask a doctor
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INGREDIENTS AND APPEARANCE
APTRIZINE 24-HOUR ALL DAY ALLERGY
cetirizine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46084-012 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) 21.66 mg STARCH, CORN (UNII: O8232NY3SJ) 85.32 mg GELATIN (UNII: 2G86QN327L) 2.4 mg METHYLPARABEN (UNII: A2I8C7HI9T) .2 mg TITANIUM DIOXIDE (UNII: 15FIX9V2JP) .1 mg MAGNESIUM STEARATE (UNII: 70097M6I30) 1.3 mg TALC (UNII: 7SEV7J4R1U) 3.9 mg SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) 3.9 mg Product Characteristics Color white (white) Score no score Shape ROUND (no score) Size 7mm Flavor Imprint Code 10mg Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46084-012-15 120 in 1 BLISTER PACK 2 NDC:46084-012-14 60 in 1 BLISTER PACK 3 NDC:46084-012-13 45 in 1 BLISTER PACK 4 NDC:46084-012-12 30 in 1 BLISTER PACK 5 NDC:46084-012-11 15 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA019835 02/21/2013 Labeler - A P J Laboratories Limited (677378339) Registrant - A P J Laboratories Limited (677378339) Establishment Name Address ID/FEI Business Operations A P J Laboratories Limited 677378339 manufacture(46084-012)