Label: CHILDRENS DYE FREE WAL ZYR- cetirizine hcl solution
- NDC Code(s): 0363-1475-26, 0363-1475-34
- Packager: Walgreen Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated December 4, 2018
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- Active ingredient (in each 5 mL)
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, sedatives, 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.
- Keep out of reach of children.
- use only with enclosed dosing cup
- find right dose on chart below
- mL = milliliter
adults and children 6 years and over
5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.
adults 65 years and over
5 mL once daily; do not take more than 5 mL in 24 hours.
children 2 to under 6 years of age
2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours.
children under 2 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor
- Inactive ingredients
Package/Label Principal Display Panel
Compare to Children’s Zyrtec® active ingredient
CETIRIZINE HYDROCHLORIDE ORAL SOLUTION 1 mg/mL /ANTIHISTAMINE
DYE & SUGAR FREE
24-hour relief of sneezing; runny nose; itchy, watery eyes & itchy throat or nose
Indoor & outdoor allergies
2 YEARS & OLDER
4 FL OZ (120 mL)
INGREDIENTS AND APPEARANCE
CHILDRENS DYE FREE WAL ZYR
cetirizine hcl solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-1475 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-1475-26 1 in 1 CARTON 11/14/2017 1 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0363-1475-34 1 in 1 CARTON 11/14/2017 2 240 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204226 11/14/2017 Labeler - Walgreen Company (008965063)