Cetirizine Hydroloride Allergy
FDA Label NDC 57664-263

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Caraco Pharmaceutical Laboratories, Ltd for the product Cetirizine Hydroloride Allergy (NDC 57664-263). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding purpose, uses, warnings, when using this product, if pregnant or breast-feeding:, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

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

If Pregnant Or Breast-Feeding:

  • 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 toll-free number 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) or store refrigerated, 2 to 8°C (36 to 46°F)

Inactive Ingredients

Artificial grape flavor, glacial acetic acid, glycerin, methylparaben, purified water, propylene glycol, propylparaben, sodium acetate, and sucrose

Questions Or Comments?


call toll-free 1-800-818-4555 weekdays

Dosing Cup Included

Dosing cup should be washed and left to air dry after each use.

Do not use if carton is opened, or if seal on bottle is broken or missing.

Dist. by:      Caraco Pharmaceutical Laboratories, Ltd.

              Detroit, Michigan 48202

Mfg. by: SUN Pharmaceutical Industries, Inc.

              Bryan, Ohio 43506


6028L01                                          Iss: 09/11

Principal Display Panel


NDC 57664-263-31
 
2 years & older

Children’s

Cetirizine

Hydrochloride

1mg / mL  Oral Solution, USP

antihistamine

ALLERGY

Indoor and Outdoor Allergies

24 Hour Relief of

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

    • Dosing Cup Included

    Do not use if carton is opened, or if seal on bottle is broken or missing.

    2 years and older

    Grape Syrup


    4 fl. oz. (120 mL)                    
     
    Image (Cetirizine Allergies)

    Image (Cetirizine Allergies)


     

* Please review the disclaimer below.