Label: PREMIER VALUE CHILDRENS CETIRIZINE- cetirizine hydrochloride solution
- NDC Code(s): 68016-165-00
- Packager: Chain Drug Constortium
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated 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 older 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 ½ 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)
- Inactive ingredients
artificial grape flavor, glacial acetic acid, glycerin, methylparaben, natural and artificial banana flavor, propylene glycol, propylparaben, purified water, sodium acetate (anhydrous), sucraloseClose
- SPL UNCLASSIFIED SECTION
DISTRIBUTED BY CHAIN DRUG CONSORTIUMClose
3301 NW BOCA RATON BLVD, SUITE 101
BOCA RATON, FL 33431
- PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
COMPARE TO THE
IN CHILDREN'S ZYRTEC®*
24 hour Allergy
Relief of: Sneezing;
Runny Nose; Itchy, Watery Eyes;
Itchy Throat or Nose
INDOOR & OUTDOOR
4 FL OZ
- INGREDIENTS AND APPEARANCE
PREMIER VALUE CHILDRENS CETIRIZINE
cetirizine hydrochloride solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-165 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 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 GRAPE (sugar free) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-165-00 1 in 1 CARTON 1 120 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090182 09/08/2011 Labeler - Chain Drug Constortium (101668460) Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceutical Industries Ltd. 600072078 MANUFACTURE(68016-165) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(68016-165)