CHILDRENS ALLERGY RELIEF- cetirizine hydrochloride solution

CHILDRENS ALLERGY RELIEF by

Drug Labeling and Warnings

CHILDRENS ALLERGY RELIEF by is a Otc medication manufactured, distributed, or labeled by Strategic Sourcing Services, Hetero Labs Limited Unit III. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

(in each 5 mL)
Cetirizine Hydrochloride USP 5mg

PURPOSE

Antihistamine

USE(S)

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• runny nose
• sneezing
• itchy, watery eyes
• itching of the nose or throat

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.

ASK A DOCTOR OR PHARMACIST BEFORE USE IF

you are taking tranquilizers or sedatives.

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).

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

Other Information

• store between 20° to 25°C (68° to 77°F)
• do not use if carton is opened or bottle wrap imprinted “SAFETY SEAL®” is broken or missing
• see top panel for lot number and expiration date

Inactive ingredients

anhydrous citric acid, flavors, non crystallizing sorbitol solution, propylene glycol, purified water, sodium benzoate and sucralose.

Questions?

call   833-358-6431
                                              
Distributed by:
McKesson Corp.,
via Strategic Sourcing Services, LLC.,
Memphis TN 38141

PRINCIPAL DISPLAY PANEL

Cetirizine Hydrochloride Oral Solution USP, 1 mg/1 mL-container label

Cetirizine Hydrochloride Oral Solution USP, 1 mg/1 mL-carton label

INGREDIENTS AND APPEARANCE

CHILDRENS ALLERGY RELIEF  
cetirizine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70677-0149
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	yellow (Colorless to Yellow)	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70677-0149-1	1 in 1 CARTON	07/21/2022
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	ANDA210622	07/21/2022

Labeler - Strategic Sourcing Services (116956644)

Establishment
Name	Address	ID/FEI	Business Operations
Hetero Labs Limited Unit III		676162024	manufacture(70677-0149)