Label: CHILDRENS ZYRTEC ALLERGY- cetirizine hydrochloride tablet, orally disintegrating
- NDC Code(s): 50580-782-01, 50580-782-12, 50580-782-24
- Packager: Johnson & Johnson Consumer Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated June 6, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
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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.
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Directions
Tablet melts in mouth. Can be taken with or without water.
adults and children 6 years and over 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?
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PRINCIPAL DISPLAY PANEL
Original Prescription Strength
NDC 50580-782-12
Children's
ZyRTEC ® ALLERGYCetirizine HCl
orally disintegrating tablets
10 mg/antihistamineIndoor + Outdoor
AllergiesDissolve Tabs
24
hourRelief of
- Sneezing
- Itchy, Watery Eyes
- Runny Nose
- Itchy Throat or Nose
6 yrs.
& older
10mg eachCitrus Flavor
Actual
SizeMelts In
Your Mouth12 ORALLY DISINTEGRATING TABLETS
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INGREDIENTS AND APPEARANCE
CHILDRENS ZYRTEC ALLERGY
cetirizine hydrochloride tablet, orally disintegratingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-782 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 DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSPOVIDONE (UNII: 2S7830E561) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color white Score no score Shape ROUND Size 11mm Flavor CITRUS Imprint Code Z10 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-782-12 2 in 1 CARTON 01/20/2014 1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:50580-782-24 4 in 1 CARTON 01/20/2014 2 6 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:50580-782-01 2 in 1 PACKAGE 01/20/2014 3 4 in 1 CARTON 3 6 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022578 01/20/2014 Labeler - Johnson & Johnson Consumer Inc. (878046358)