CHILDRENS ALLERGY RELIEF- cetirizine hydrochloride solution

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

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 1-888-588-1418

Distributed by:
Camber Consumer Care, Inc.
Piscataway, NJ 08854, USA.

Mfg. Lic. No.: 22/RR/AP/2001/F/R
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

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 69230-316-11	1 in 1 CARTON	03/13/2019
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA210622	03/13/2019

Labeler - Camber Consumer Care (079539968)

Name	Address	ID/FEI	Business Operations
Establishment
Hetero Labs Limited Unit III		676162024	ANALYSIS(69230-316) , MANUFACTURE(69230-316)

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