Label: CETIRIZINE HYDROCHLORIDE (ALLERGY)- cetirizine hydrochloride tablet
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NDC Code(s):
68788-8204-0,
68788-8204-1,
68788-8204-3,
68788-8204-5, view more68788-8204-6, 68788-8204-9
- Packager: Preferred Pharmaceuticals Inc.
- This is a repackaged label.
- Source NDC Code(s): 58602-445
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 9, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
- Warnings
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding:
- Keep out of reach of children.
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Directions
For 5 mg: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 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
For 10 mg:
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
- Questions?
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg
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INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROCHLORIDE (ALLERGY)
cetirizine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-8204(NDC:58602-445) 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (White to Off-white) Score no score Shape ROUND Size 8mm Flavor Imprint Code X;36 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68788-8204-1 14 in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2022 2 NDC:68788-8204-5 15 in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2022 3 NDC:68788-8204-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2022 4 NDC:68788-8204-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2022 5 NDC:68788-8204-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2022 6 NDC:68788-8204-0 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090760 04/01/2022 Labeler - Preferred Pharmaceuticals Inc. (791119022) Registrant - Preferred Pharmaceuticals Inc. (791119022) Establishment Name Address ID/FEI Business Operations Preferred Pharmaceuticals Inc. 791119022 REPACK(68788-8204)