Label: CHILDRENS ZYRTEC- cetirizine hydrochloride tablet, chewable
- NDC Code(s): 50580-790-01, 50580-790-02, 50580-790-03
- Packager: Johnson & Johnson Consumer Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated August 8, 2024
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each chewable 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
- may be taken with or without water
- chew or crush tablets completely before swallowing
children 2 to under 6 years of age Chew and swallow 1 tablet (2.5 mg) once daily; If needed, dose can be increased to a maximum of 2 tablets (5 mg) once daily or 1 tablet (2.5 mg) every 12 hours. Do not give more than 2 tablets (5 mg) in 24 hours. adults and children 6 years and over Chew and swallow 2 tablets (5 mg) or 4 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 4 tablets (10 mg) in 24 hours. adults 65 years and over Chew and swallow 2 tablets (5 mg) once daily; do not take more than 2 tablets (5 mg) 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?
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PRINCIPAL DISPLAY PANEL
NDC 50580-790-01
Children's
ZYRTEC ®Cetirizine HCl chewable tablets,
2.5 mg/antihistamineALLERGY
INDOOR + OUTDOOR
ALLERGIESDye-Free
Chewables24
HOUR
RELIEF OF- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
2 yrs.
& olderGrape Flavor
Actual
Size2.5 mg
12 Chewable TabletsChew or crush tablets completely
before swallowing -
INGREDIENTS AND APPEARANCE
CHILDRENS ZYRTEC
cetirizine hydrochloride tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-790 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE 2.5 mg Inactive Ingredients Ingredient Name Strength BETADEX (UNII: JV039JZZ3A) STARCH, CORN (UNII: O8232NY3SJ) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color white Score no score Shape ROUND Size 8mm Flavor GRAPE Imprint Code CTZ Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-790-01 2 in 1 CARTON 06/21/2021 1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:50580-790-02 4 in 1 CARTON 06/21/2021 2 6 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:50580-790-03 1 in 1 CARTON 09/01/2022 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 NDA021621 06/21/2021 Labeler - Johnson & Johnson Consumer Inc. (878046358)