Label: INDOOR OUTDOOR ALLERGIES- cetirizine hcl tablet
- NDC Code(s): 63548-0739-3
- Packager: PLD Acquisitions LLC DBA Avéma Pharma Solutions
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 9, 2023
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 tablet)
- Purpose
- Uses
-
Warnings
Do not use
if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
Ask a doctor before use if you have
liver or kidney disease. Your doctor should determine if you need a different dose
When using this product
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedative, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
an allergic reaction to this product occurs. Seek medical help right away.
-
Directions
adults and children 6 years and over Take 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 or comments?
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Principal Display Panel
*Compare to the active ingredient in Zyrtec®
Cetirizine HCL Tablets, USP 10 mg
Antihistamine
Indoor & Outdoor allergies
24 hour relief of
- sneezing
- Runny nose
- Itchy, watery eyes
- Itchy throat or nose
Tablets
*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Zyrtec®
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
- Product Label
-
INGREDIENTS AND APPEARANCE
INDOOR OUTDOOR ALLERGIES
cetirizine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63548-0739 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) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code 432 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63548-0739-3 1 in 1 BOX 07/01/2019 1 300 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077946 07/01/2019 Labeler - PLD Acquisitions LLC DBA Avéma Pharma Solutions (804087794)