Cetirizine Hydrochloride Syrup

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

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

PRINCIPAL DISPLAY PANEL - Cup, Unit-Dose Label

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

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)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0121-4780-05	4 in 1 CASE	09/15/2009	08/30/2013
1		10 in 1 TRAY
1		5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA090300	09/15/2009	08/30/2013

Labeler - PAI Holdings, LLC (044940096)

Name	Address	ID/FEI	Business Operations
Establishment
PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma		044940096	manufacture(0121-4780) , repack(0121-4780)

Revised: 6/2023

Document Id: 21e6bc29-c6b4-44c9-883d-8b96881e8776

Set id: f621a02d-5a92-4aa2-af70-1fd1d993ba75

Version: 4

Effective Time: 20230615

PAI Holdings, LLC