CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)
Available from:
QUAGEN PHARMACEUTICALS LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antihistamine 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
Authorization status:
Abbreviated New Drug Application
Authorization number:
70752-103-06, 70752-104-06

CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride solution

QUAGEN PHARMACEUTICALS LLC

----------

Children's Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL (Bubble Gum & Grape Flavor)

Important: Read all product information before using. Keep this box for important information.

This product is intended for use in children.

DRUG FACTS

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

Ques tions ?

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

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

CETIRIZINE HYDROCHLORIDE

cetirizine hydrochloride solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 752-10 3

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CETIRIZINE HYDRO CHLO RIDE (UNII: 6 4O0 47KTOA) (CETIRIZINE -

UNII:YO726 1ME24)

CETIRIZINE

HYDROCHLORIDE

1 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

SO RBITO L (UNII: 50 6 T6 0 A25R)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

Product Characteristics

Color

S core

S hap e

S iz e

Flavor

BUBBLE GUM

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:70 752-10 3-

1 in 1 CARTON

0 5/17/20 19

1

118 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA21226 6

0 5/17/20 19

CETIRIZINE HYDROCHLORIDE

cetirizine hydrochloride solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 752-10 4

Route of Administration

ORAL

Active Ingredient/Active Moiety

QUAGEN PHARMACEUTICALS LLC

Ingredient Name

Basis of Strength

Stre ng th

CETIRIZINE HYDRO CHLO RIDE (UNII: 6 4O0 47KTOA) (CETIRIZINE -

UNII:YO726 1ME24)

CETIRIZINE

HYDROCHLORIDE

1 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

SO RBITO L (UNII: 50 6 T6 0 A25R)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

Product Characteristics

Color

S core

S hap e

S iz e

Flavor

GRAPE

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:70 752-10 4-

1 in 1 CARTON

0 5/17/20 19

1

118 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA21226 6

0 5/17/20 19

Labeler -

QUAGEN PHARMACEUT ICALS LLC (073645339)

Registrant -

QUAGEN PHARMACEUT ICALS LLC (073645339)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

QUAGEN PHARMACEUTICALS LLC

0 8 0 28 1331

manufacture(70 752-10 3, 70 752-10 4) , pack(70 752-10 3, 70 752-10 4)

Revised: 5/2019

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