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Cetirizine Hydrochloride by Pharmaceutical Associates, Inc.

Dosage form: syrup
Ingredients: Cetirizine Hydrochloride 5mg in 5mL
Labeler: Pharmaceutical Associates, Inc.
NDC Code: 0121-4780

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

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-4780(NDC:60258-860)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Cetirizine Hydrochloride (Cetirizine) Cetirizine Hydrochloride5 mg  in 5 mL
Product Characteristics
ColorYELLOW (Slightly Yellow) Score    
ShapeSize
FlavorBANANA, GRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0121-4780-054 TRAY (TRAY) in 1 CASE
110 CUP, UNIT-DOSE (CUP) in 1 TRAY
15 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09030009/15/2009
Labeler - Pharmaceutical Associates, Inc. (044940096)
Establishment
NameAddressID/FEIOperations
Pharmaceutical Associates, Inc.044940096MANUFACTURE, REPACK
Establishment
NameAddressID/FEIOperations
Cypress Pharmaceutical, Inc.790248942MANUFACTURE
Establishment
NameAddressID/FEIOperations
Therapex204211163MANUFACTURE

 
Pharmaceutical Associates, Inc.

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Medically reviewed on Sep 14, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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