Label: CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride allergy tablet
- NDC Code(s): 70000-0047-1
- Packager: Cardinal Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 16, 2021
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- 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.
-
Directions
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 (365's Tablets Bottle)
LEADERTM
NDC 70000-0047-1
Original Prescription Strength
All Day Allergy
Cetirizine Hydrochloride Tablets
USP, 10 mg | Antihistamine
COMPARE TO
ZYRTEC®
active ingredient*
Indoor and
Outdoor Allergies
24-Hour Relief of:
Sneezing; Runny Nose; Itchy,
Watery Eyes; Itchy Throat or Nose
365 TABLETS
10 mg EACH
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INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride allergy tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0047 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:70000-0047-1 365 in 1 BOTTLE; Type 0: Not a Combination Product 03/26/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090760 03/26/2020 Labeler - Cardinal Health (063997360) Registrant - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurobindo Pharma Limited 918917642 ANALYSIS(70000-0047) , MANUFACTURE(70000-0047)