![DYE FREE CHILDRENS CETIRIZINE HYDROCHOLRIDE (CETIRIZINE HYDROCHLORIDE) SOLUTION [PRECISION DOSE, INC.]](https://medic.hrt.org//dailymed/images/6a7c4dff-66c6-4d0c-af10-d908c65a43be/dye-01.jpg)
| NDC | 68094-004-59, 68094-004-62 |
| Set ID | 6a7c4dff-66c6-4d0c-af10-d908c65a43be |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Precision Dose, Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | ANDA204226 |
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL)
- 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
- Use as directed per healthcare professional.
- mL = milliliter
adults and children 6 years and over 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours. adults 65 years and over 5 mL once daily; do not take more than 5 mL in 24 hours. children 2 to under 6 years of age 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 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
- SPL UNCLASSIFIED SECTION
- How Supplied
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
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INGREDIENTS AND APPEARANCE
DYE FREE CHILDRENS CETIRIZINE HYDROCHOLRIDE
cetirizine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68094-004(NDC:0113-0503) 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 anhydrous citric acid (UNII: XF417D3PSL) propylene glycol (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) sodium benzoate (UNII: OJ245FE5EU) sorbitol (UNII: 506T60A25R) sucralose (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68094-004-62 3 in 1 CASE 10/26/2016 1 10 in 1 TRAY 1 NDC:68094-004-59 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204226 10/26/2016 Labeler - Precision Dose, Inc. (035886746)
