CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride liquid
Tris Pharma Inc

----------

Cetirizine Hydrochloride Oral Solution

Drug Facts

(Allergy)

ACTIVE INGREDIENT(in each 5 mL)

Cetirizine Hydrochloride 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

Warnings

DO NOT USE

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 DOCTOR

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

WHEN USING

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

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding:

■ If breast-feeding: not recommended

■ if pregnant: ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

adults and children 6 years and over	1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.
adults 65 years and over	1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours
children 2 to under 6 years of age	½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (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 neckband imprinted “sealed for protection” is broken or missing

INACTIVE INGREDIENT

banana flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate anhydrous, sucrose.

QUESTIONS

call 1-732-940-0358

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Allergy

1 mg/mL

4 fl oz (118 mL)

CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:27808-001
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	5 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
ACETIC ACID (UNII: Q40Q9N063P)
BANANA (UNII: 4AJZ4765R9)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM ACETATE ANHYDROUS (UNII: NVG71ZZ7P0)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	YELLOW (slightly)	Score
Shape		Size
Flavor	BANANA	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:27808-001-01	30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	11/21/2012	12/13/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090572	11/21/2012	12/13/2016

Labeler - Tris Pharma Inc (947472119)

Revised: 12/2016

Document Id: 99fefbd2-ab02-4a9d-acf1-1a29a392752f

Set id: 17c60b47-ea3b-4c8d-b1f5-9975a8c143a7

Version: 2

Effective Time: 20161212

Tris Pharma Inc