Label: CHILDRENS CETIRIZINE HYDROCHLORIDE- cetirizine hcl solution
- NDC Code(s): 0904-6765-20
- Packager: Major Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 26, 2020
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- Official Label (Printer Friendly)
- Active ingredient (in each 5 mL)
- 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, sedatives, and tranquilizers may increase drowsiness
- •
- be careful when driving a motor vehicle or operating machinery
- Keep out of reach of children.
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Directions
- •
- 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 the active ingredient of CHILDREN’S ZYRTEC®
Children’s Cetirizine Hydrochloride Oral Solution 1 mg/mL
Antihistamine
ALLERGY
INDOOR & OUTDOOR ALLERGIES
24 HOUR RELIEF OF:
Sneezing / Runny Nose
Itchy, Watery Eyes / Itchy Throat or Nose
4 FL OZ
24 Hour
(118 mL)
2yrs & older
Dosing Cup Included
Dye-Free
Sugar-Free
Grape Flavored Syrup
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INGREDIENTS AND APPEARANCE
CHILDRENS CETIRIZINE HYDROCHLORIDE
cetirizine hcl solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6765 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:0904-6765-20 1 in 1 CARTON 08/22/2018 1 118 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 08/22/2018 Labeler - Major Pharmaceuticals (191427277)