Label: CHILDRENS ALLERGY RELIEF- cetirizine hydrochloride solution
- NDC Code(s): 49035-106-08
- Packager: Wal-Mart Stores Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 14, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- 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
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
- 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 - Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
NDC 49035-106-08
equate™
Compare to
Children's
Zyrtec® active
ingredient*children*s
CETIRIZINE
HYDROCHLORIDE
ORAL SOLUTION
1 mg/mL
Antihistamine (Allergy)2 YEARS AND OLDER
24 Hour Relief of:
- Sneezing
- Runny nose
- Itchy, watery eyes
- Itchy throat or nose
LASTS UP TO
24
HOURSIndoor and
Outdoor Allergies- Alcohol Free
- Sugar Free
Dye Free
Bubble Gum
Flavor4 FL OZ (120 mL)
Dosage Cup
Included -
INGREDIENTS AND APPEARANCE
CHILDRENS ALLERGY RELIEF
cetirizine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-106 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 anhydrous (UNII: NVG71ZZ7P0) sucralose (UNII: 96K6UQ3ZD4) Product Characteristics Color YELLOW (colorless to slightly yellow) Score Shape Size Flavor BUBBLE GUM (Sugar Free) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-106-08 1 in 1 CARTON 05/20/2011 1 120 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 ANDA201546 05/20/2011 Labeler - Wal-Mart Stores Inc (051957769)