Childrens Allergy Relief Solution
FDA Label NDC 70677-0149

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services for the product Childrens Allergy Relief (NDC 70677-0149). 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 active ingredient(s), purpose, use(s), do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient(S)

(in each 5 mL)
Cetirizine Hydrochloride USP 5mg


Purpose

Antihistamine

Use(S)

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

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 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 (1-800-222-1222).

Directions


  • use only with enclosed dosing cup
  • find right dose on chart below
  • mL = milliliter


    • adults and children 6 years and over
    		5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.
    adults 65 years and over
    		5 mL once daily; do not take more than 5 mL in                  24 hours.
    children 2 to under 6 years of age
    		2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every                   12 hours. Do not give more than 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 bottle wrap imprinted “SAFETY SEAL®” is broken or missing
  • see top panel for lot number and expiration date

Inactive Ingredients

anhydrous citric acid, flavors, non crystallizing sorbitol solution, propylene glycol, purified water, sodium benzoate and sucralose.

Questions?

call   833-358-6431
                                              
Distributed by:
McKesson Corp.,
via Strategic Sourcing Services, LLC.,
Memphis TN 38141


Principal Display Panel


Cetirizine Hydrochloride Oral Solution USP, 1 mg/1 mL-container label


Cetirizinehclos-contlabel (Cetirizinehclos Contlabel)

Cetirizinehclos-contlabel (Cetirizinehclos Contlabel)



Cetirizine Hydrochloride Oral Solution USP, 1 mg/1 mL-carton label

Carton-cetirizineos (Carton Cetirizineos)

Carton-cetirizineos (Carton Cetirizineos)


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