Label: CHILDRENS ZYRTEC- cetirizine hydrochloride syrup
- NDC Code(s): 50580-730-04, 50580-730-09, 50580-730-15
- Packager: McNeil Consumer Healthcare Div McNeil-PPC, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL teaspoonful)
Cetirizine HCl 5 mgClose
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- itching of the nose or throat
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.
If pregnant or breast-feeding:
- if breast-feeding: not recommended
- if pregnant: ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
- use only with enclosed dosing cup
adults and children 6 years and over 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. adults 65 years and over 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. children 2 to under 6 years of age 1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (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
- store between 20° to 25°C (68° to 77°F)
- do not use if carton is opened; or if bottle wrap or foil inner seal printed with "Safety Seal®" is broken or missing
- see bottom panel for lot number and expiration date
- PRINCIPAL DISPLAY PANEL
1 mg/mL oral solution
Indoor & Outdoor Allergies
•Itchy, Watery Eyes
•Itchy Throat or Nose
Dye-Free • Sugar-Free
4 FL OZ (118 mL)
Dosing Cup Included
- INGREDIENTS AND APPEARANCE
cetirizine hydrochloride syrup
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-730 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cetirizine Hydrochloride (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24) Cetirizine Hydrochloride 5 mg in 5 mL Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-730-04 1 in 1 CARTON 1 118 mL in 1 BOTTLE, PLASTIC 2 NDC:50580-730-09 2 in 1 PACKAGE, COMBINATION 2 118 mL in 1 BOTTLE, PLASTIC 3 NDC:50580-730-15 12 in 1 CARTON 3 15 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022155 06/01/2009 Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)