Label: GOOD SENSE CHILDRENS ALL DAY ALLERGY- cetirizine hcl solution
- NDC Code(s): 0113-0503-26
- Packager: L. Perrigo Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated March 25, 2016
If you are a consumer or patient please visit this version.
- Active ingredient (in each 5 mL)
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)Close
- 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
- store between 20° to 25°C (68° to 77°F)
- do not use if carton is opened, or if printed neckband is broken or missing
- see bottom panel for lot number and expiration date
- Inactive ingredients
anhydrous citric acid, artificial grape flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucraloseClose
- Package/Label Principal Display Panel
2 Yrs. & Older
Children’s All Day Allergy
Cetirizine Hydrochloride Oral Solution 1 mg/mL
24 Hour Relief of:
Itchy, Watery Eyes
Itchy Throat or Nose
Indoor & Outdoor Allergies
Dosing Cup Included
Compare to active ingredient of Children’s Zyrtec®
4 FL OZ (118 mL)Close
- INGREDIENTS AND APPEARANCE
GOOD SENSE CHILDRENS ALL DAY ALLERGY
cetirizine hcl solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) 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:0113-0503-26 1 in 1 CARTON 1 118 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 01/11/2016 Labeler - L. Perrigo Company (006013346)