Label: CETIRIZINE HYDROCHLORIDE tablet
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NDC Code(s):
71335-0300-1,
71335-0300-2,
71335-0300-3,
71335-0300-4, view more71335-0300-5, 71335-0300-6, 71335-0300-7, 71335-0300-8, 71335-0300-9
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 16571-402
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 25, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Purpose
- 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 overone 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
- Questions?
- SPL UNCLASSIFIED SECTION
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HOW SUPPLIED
NDC: 71335-0300-1: 30 Tablets in a BOTTLE
NDC: 71335-0300-2: 14 Tablets in a BOTTLE
NDC: 71335-0300-3: 7 Tablets in a BOTTLE
NDC: 71335-0300-4: 10 Tablets in a BOTTLE
NDC: 71335-0300-5: 15 Tablets in a BOTTLE
NDC: 71335-0300-6: 90 Tablets in a BOTTLE
NDC: 71335-0300-7: 20 Tablets in a BOTTLE
NDC: 71335-0300-8: 60 Tablets in a BOTTLE
NDC: 71335-0300-9: 100 Tablets in a BOTTLE
Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504
- 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:71335-0300(NDC:16571-402) 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 HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (White) Score no score Shape BULLET (Barrel Shaped) Size 8mm Flavor Imprint Code CTN;10 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71335-0300-1 30 in 1 BOTTLE; Type 0: Not a Combination Product 02/16/2018 2 NDC:71335-0300-2 14 in 1 BOTTLE; Type 0: Not a Combination Product 02/20/2018 3 NDC:71335-0300-3 7 in 1 BOTTLE; Type 0: Not a Combination Product 02/09/2022 4 NDC:71335-0300-4 10 in 1 BOTTLE; Type 0: Not a Combination Product 03/19/2019 5 NDC:71335-0300-5 15 in 1 BOTTLE; Type 0: Not a Combination Product 02/09/2022 6 NDC:71335-0300-6 90 in 1 BOTTLE; Type 0: Not a Combination Product 02/16/2018 7 NDC:71335-0300-7 20 in 1 BOTTLE; Type 0: Not a Combination Product 03/07/2019 8 NDC:71335-0300-8 60 in 1 BOTTLE; Type 0: Not a Combination Product 10/13/2021 9 NDC:71335-0300-9 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/03/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077829 10/01/2009 Labeler - Bryant Ranch Prepack (171714327) Registrant - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(71335-0300) , RELABEL(71335-0300)