Label: CHILDRENS ALLERGY- cetirizine hcl liquid
- NDC Code(s): 63868-430-04
- Packager: QUALITY CHOICE (Chain Drug Marketing Association)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 2, 2021
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 5 mL teaspoonful)
- 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
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- 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
- use only with enclosed dosing cup
adults and children 6 years and over 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. adults 65 years and over 1 teaspoonful (5 ML) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours children 2 to under 6 years of age 1/2 teaspoonful (2.5 mL) once dailly. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
*Compare to the active ingredient in Children's Zyrtec®
Children's Allergy
Indoor & Outdoor Allergies
Cetirizine Oral Solution
1mg/mL | Antihistamine
24-Hour relief of:
Sneezing
Runny nose
Itchy, watery eyes
Itchy throat or nose
For Ages 2 Years & Older
Dye-free
Grape Flavor
Dosing Cup Included
FL OZ (mL)
*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Zyrtec®
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Dosing cup should be washed and left to air dry after each use
Distributed by C.D.M.A Inc.
43157 W. Nine Mile
Novi, MI 48376-0995
- Package Label
-
INGREDIENTS AND APPEARANCE
CHILDRENS ALLERGY
cetirizine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-430 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE 5 mg in 5 mL Inactive Ingredients Ingredient Name Strength ACETIC ACID (UNII: Q40Q9N063P) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM ACETATE (UNII: 4550K0SC9B) SUCROSE (UNII: C151H8M554) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-430-04 1 in 1 BOX 12/31/2014 05/31/2024 1 118 mL 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 ANDA090474 12/31/2014 05/31/2024 Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)
