![WESTERN FAMILY CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [WESTERN FAMILY FOODS INC]](https://medic.hrt.org//dailymed/images/e933e011-6a65-4b12-97c5-1521a22fb909/cetirizine-01.jpg)
| NDC | 55312-106-08 |
| Set ID | e933e011-6a65-4b12-97c5-1521a22fb909 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Western Family Foods Inc |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | ANDA201546 |
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL teaspoonful)
- 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.
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Directions
- 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
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
WESTERN
FAMILY®INDOOR & OUTDOOR ALLERGIES
Children's
Allergy
RELIEFCETIRIZINE HYDROCHLORIDE
ORAL SOLUTION 1 mg / mL
Antihistamine2 years
and olderBubblegum
flavored24 HOUR RELIEF OF:
- ✓
- SNEEZING
- ✓
- RUNNY NOSE
- ✓
- ITCHY, WATERY EYES
- ✓
- ITCHY THROAT OR NOSE
4 FL OZ (120 mL)
COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S ZYRTEC®*
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INGREDIENTS AND APPEARANCE
WESTERN FAMILY CHILDRENS ALLERGY RELIEF
cetirizine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55312-106 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:55312-106-08 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 ANDA201546 05/20/2011 Labeler - Western Family Foods Inc (192166072) Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceutical Industries Ltd. 600072078 MANUFACTURE(55312-106)