CETIRIZINE HYDROCHLORIDE syrup

Cetirizine Hydrochloride by

Drug Labeling and Warnings

Cetirizine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Pharmaceutical Associates, Inc., Cypress Pharmaceutical, Inc., Therapex. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 5 mL teaspoonful)

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

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 pregnant: ask a health professional before use
• if breast-feeding: not recommended

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• 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: 1⁄2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1⁄2 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)
• colorless to slightly yellow, banana-grape flavored liquid supplied in the following oral dosage form: NDC 0121-4780-05 (unit dose cups of 5 mL)

Inactive ingredients

flavors, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, sodium acetate, sugar, and purified water.

Questions or comments?

Call 1-800-845-8210

SPL UNCLASSIFIED SECTION

R07/09

Manufactured by:
Cypress Pharmaceutical, Inc.
Madison, MS 39110

Packaged by:
Pharmaceutical
Associates, Inc.
Greenville, SC 29605
www.paipharma.com

PRINCIPAL DISPLAY PANEL - Cup, Unit-Dose Label

Delivers 5 mL
NDC: 0121-4780-05

CETIRIZINE
HYDROCHLORIDE
SYRUP

5 mg/5 mL

FOR INSTITUTIONAL USE ONLY

Mfg. by: CYPRESS PHARMACEUTICAL, INC.
MADISON, MS 39110
pkg. by: PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605

SEE INSERT

A47800500

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0121-4780(NDC: 60258-860)
Route of Administration	ORAL

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

Product Characteristics
Color	YELLOW (Slightly Yellow)	Score
Shape		Size
Flavor	BANANA, GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0121-4780-05	4 in 1 CASE
1		10 in 1 TRAY
1		5 mL in 1 CUP, UNIT-DOSE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090300	09/15/2009

Labeler - Pharmaceutical Associates, Inc. (044940096)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaceutical Associates, Inc.		044940096	MANUFACTURE, REPACK

Establishment
Name	Address	ID/FEI	Business Operations
Cypress Pharmaceutical, Inc.		790248942	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Therapex		204211163	MANUFACTURE