Label: ALLERGY RELIEF- cetirizine hcl tablet
- NDC Code(s): 72090-028-01
- Packager: Pioneer Life Sciences, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 3, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient (in each caplet)
- Purpose
- Uses:
- Warnings:
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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Directions
Adults and children 6 years and older: 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 lnfonnation
- Inactive Ingredients
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ALLERGY RELIEF
cetirizine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72090-028 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 LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STARCH, CORN (UNII: O8232NY3SJ) POVIDONE (UNII: FZ989GH94E) Product Characteristics Color white Score no score Shape BULLET (Barrel shape) Size 8mm Flavor Imprint Code CTN;10 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72090-028-01 300 in 1 BOTTLE; Type 0: Not a Combination Product 10/03/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077829 10/03/2024 Labeler - Pioneer Life Sciences, LLC (014092742) Registrant - Pioneer Life Sciences, LLC (014092742)