![KIRKLAND SIGNATURE CHILDRENS ALLER TEC (CETIRIZINE HCL) SOLUTION [COSTCO WHOLESALE COMPANY]](https://medic.hrt.org//dailymed/images/eb14a311-7918-4c4b-ae05-7606cfb8a4af/A90005NC2 Image 1.jpg)
![KIRKLAND SIGNATURE CHILDRENS ALLER TEC (CETIRIZINE HCL) SOLUTION [COSTCO WHOLESALE COMPANY]](https://medic.hrt.org//dailymed/images/eb14a311-7918-4c4b-ae05-7606cfb8a4af/A90005NC2 Image 2.jpg)
| NDC | 63981-475-34, 63981-475-43 |
| Set ID | eb14a311-7918-4c4b-ae05-7606cfb8a4af |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Costco Wholesale Company |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | ANDA204226 |
- Active ingredient (in each 5 mL)
- 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
- Keep out of reach of children.
-
Directions
- •
- use only with enclosed dosing cup
- •
- find right dose on chart below
- •
- 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
- Inactive Ingredients
-
Package/Label Principal Display Panel
COMPARE TO CHILDREN’S ZYRTEC® active ingredient
CHILDREN’S
ALLER-TEC®
Cetirizine Hydrochloride Oral Solution 1 mg/mL Antihistamine
Indoor & Outdoor Allergies
Allergy
24 Hour Relief of:
Itcy, Watery Eyes
Itchy Throat or Nose
Sneezing
Runny Nose
Sugare Free
Dye Free
Grape Flavor
2 x 8 Fl oz bottles
Total 16 Fl oz (1 pint) 480 mL
2 Years & Older
-
INGREDIENTS AND APPEARANCE
KIRKLAND SIGNATURE CHILDRENS ALLER TEC
cetirizine hcl solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63981-475 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:63981-475-43 2 in 1 CARTON 07/08/2016 1 NDC:63981-475-34 240 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204226 07/08/2016 Labeler - Costco Wholesale Company (103391843)
