Label: CETIRIZINE HYDROCHLORIDE (ALLERGY)- cetirizine hydrochloride tablet
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NDC Code(s):
71205-700-00,
71205-700-06,
71205-700-10,
71205-700-12, view more71205-700-14, 71205-700-15, 71205-700-20, 71205-700-21, 71205-700-30, 71205-700-60, 71205-700-72, 71205-700-90
- Packager: Proficient Rx LP
- 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 March 1, 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 (10's Tablet Container Carton Label)
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INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROCHLORIDE (ALLERGY)
cetirizine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71205-700(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:71205-700-06 6 in 1 BOTTLE; Type 0: Not a Combination Product 01/29/2024 2 NDC:71205-700-10 10 in 1 BOTTLE; Type 0: Not a Combination Product 10/20/2022 3 NDC:71205-700-12 12 in 1 BOTTLE; Type 0: Not a Combination Product 01/29/2024 4 NDC:71205-700-14 14 in 1 BOTTLE; Type 0: Not a Combination Product 01/29/2024 5 NDC:71205-700-15 15 in 1 BOTTLE; Type 0: Not a Combination Product 01/29/2024 6 NDC:71205-700-20 20 in 1 BOTTLE; Type 0: Not a Combination Product 01/29/2024 7 NDC:71205-700-21 21 in 1 BOTTLE; Type 0: Not a Combination Product 01/29/2024 8 NDC:71205-700-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 09/16/2022 9 NDC:71205-700-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 09/16/2022 10 NDC:71205-700-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 09/16/2022 11 NDC:71205-700-00 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/08/2024 12 NDC:71205-700-72 120 in 1 BOTTLE; Type 0: Not a Combination Product 03/08/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090760 08/05/2015 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 REPACK(71205-700) , RELABEL(71205-700)