CETIRIZINE HYDROCHLORIDE solution

CETIRIZINE HYDROCHLORIDE by

Drug Labeling and Warnings

CETIRIZINE HYDROCHLORIDE by is a Otc medication manufactured, distributed, or labeled by QUAGEN PHARMACEUTICALS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 5 mL)

Cetirizine HCl 5 mg

Purpose

Antihistamine

Uses

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.
• Side effects occur: You may report side effects to FDA at 1-800-FDA-1088.

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)
• Protect from light
• do not use if carton is opened or if carton tape or bottle wrap imprinted "SEALED FOR YOUR PROTECTION" is broken or missing
• see bottom panel for lot number and expiration date

Inactive ingredients

Bubble Gum Syrup: anhydrous citric acid, artificial bubble gum flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Grape Syrup: anhydrous citric acid, artificial grape flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

Questions?

Call 1-888-344-9603 (toll-free)

SPL UNCLASSIFIED SECTION

Manufactured by:
Quagen Pharmaceuticals LLC
West Caldwell, NJ 07006

51001 & 51002
Rev. 10/18

PRINCIPAL DISPLAY PANEL - Bubble Gum Flavor - Container Label

PRINCIPAL DISPLAY PANEL - Bubble Gum Flavor - Carton Label

PRINCIPAL DISPLAY PANEL - Grape Flavor - Container Label

PRINCIPAL DISPLAY PANEL - Grape Flavor-Carton Label

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70752-103
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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70752-103-06	1 in 1 CARTON	05/17/2019
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA212266	05/17/2019

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70752-104
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)
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: 70752-104-06	1 in 1 CARTON	05/17/2019
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA212266	05/17/2019

Labeler - QUAGEN PHARMACEUTICALS LLC (073645339)

Registrant - QUAGEN PHARMACEUTICALS LLC (073645339)

Establishment
Name	Address	ID/FEI	Business Operations
QUAGEN PHARMACEUTICALS LLC		080281331	manufacture(70752-103, 70752-104) , pack(70752-103, 70752-104)