Label: CETIRIZINE HYDROCHLORIDE tablet, chewable
-
Contains inactivated NDC Code(s)
NDC Code(s): 68016-353-30 - Packager: Chain Drug Consortium, LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated September 6, 2013
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each chewable tablet)
- Purpose
- Uses
- Warnings
- Do not use
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding:
- Keep out of reach of children
-
Directions
- may be taken with or without water
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
acesulfame potassium, colloidal silicon dioxide, compressible sugar, crospovidone, FD & C Blue No # 2 Aluminum Lake, FD & C Red No # 40 Aluminum Lake, guar gum, magnesium oxide light powder, magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch, prosweet N & A flavor powder, talc, tutti frutti flavor
- Questions?
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-353 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 ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SUCROSE (UNII: C151H8M554) CROSPOVIDONE (UNII: 68401960MK) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C RED NO. 40 (UNII: WZB9127XOA) GUAR GUM (UNII: E89I1637KE) MAGNESIUM OXIDE (UNII: 3A3U0GI71G) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color PURPLE Score no score Shape ROUND Size 10mm Flavor TUTTI FRUTTI Imprint Code 344 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-353-30 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090142 09/10/2013 Labeler - Chain Drug Consortium, LLC (101668460) Registrant - Sun Pharmaceutical Industries Limited (650172430) Establishment Name Address ID/FEI Business Operations Sun Pharmaceutical Industries Limited 725959238 MANUFACTURE(68016-353)