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:
A-S Medication Solutions
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antihistamine temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
Product summary:
Product: 50090-4173 NDC: 50090-4173-0 118 mL in a BOTTLE / 1 in a CARTON
Authorization status:
Abbreviated New Drug Application
Authorization number:
50090-4173-0

CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride solution

A-S Medication Solutions

----------

Perrigo Children's Cetirizine Hydrochloride Oral Solution 1 mg/mL Drug Facts

Active ingredient (in each 5 mL)

Cetirizine HCl 5 mg

Purpos e

Antihistamine

Us es

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

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

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

runny nose

sneezing

itchy, watery eyes

itching of the nose or throat

drowsiness may occur

avoid alcoholic drinks

alcohol, sedatives, and tranquilizers may increase drowsiness

be careful when driving a motor vehicle or operating machinery

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

Inactive ingredients

artificial grape flavor, glacial acetic acid, glycerin, methylparaben, natural banana flavor, propylene

glycol, propylparaben, purified water, sodium acetate, sucrose

Questions or comments?

1-800-719-9260

HOW SUPPLIED

Product: 50090-4173

NDC: 50090-4173-0 118 mL in a BOTTLE / 1 in a CARTON

cetirizine hydrochloride

use only with enclosed dosing cup

find right dose on chart below

mL = milliliter

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

CETIRIZINE HYDROCHLORIDE

cetirizine hydrochloride solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:50 0 9 0 -4173(NDC:458 0 2-9 74)

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

5 mg

in 5 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ACETIC ACID (UNII: Q40 Q9 N0 6 3P)

GLYCERIN (UNII: PDC6 A3C0 OX)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

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

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM ACETATE (UNII: 4550 K0 SC9 B)

SUCRO SE (UNII: C151H8 M554)

Product Characteristics

Color

YELLOW (Pale Yello w)

S core

S hap e

S iz e

Flavor

GRAPE

Imprint Code

Contains

Packag ing

A-S Medication Solutions

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:50 0 9 0 -4173-0

1 in 1 CARTON

0 3/0 7/20 19

1

118 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 9 0 254

0 4/15/20 0 8

Labeler -

A-S Medication Solutions (830016429)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

A-S Medicatio n So lutio ns

8 30 0 16 429

RELABEL(50 0 9 0 -4173)

Revised: 3/2019

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