Childrens Cold And Cough Liquid
FDA Label NDC 51316-578

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs for the product Childrens Cold And Cough (NDC 51316-578). 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 ingradients (in each 10 ml), purposes, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingradients (In Each 10 Ml)

Brompheniramine maleate, USP 2 mg

Dextromethorphan HBr, USP 10  mg

Phenylephrine HCl, USP 5 mg

Purposes

Antihistamine

Cough Suppressant

Nasal decongestant

Uses

  • temporarily relieves cough due to minor bronchial irritation as may occur with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies
    • temporarily relieves these symptoms due to hay fever (allergic rhinitis):
      • sneezing
      • Itching of the nose or throat
      • runny nose
      • itchy, watery eyes
        • temporarily restores freer breathing through the nose

Warnings

.

Do Not Use

  • to sedate a child or to make a child sleepy
    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, or  psychiatric, for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask A Doctor Before Use If You Have

  • heart disease
  • glaucoma
  • diabetes
  • thyroid disease
  • high blood pressure
  • difficulty in urination due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are

  • taking any other oral nasal decongestant or stimulant
  • taking sedative or tranquilizers

When Using This Product

  • do not take more than directed
  • may cause drowsiness
  • alcohol, sedatives, and tranquillizers may increase drowsiness
  • avoid alcoholic beverages
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop Use And Ask A Doctor If

  • nervousness, dizziness or sleeplessness occur
  • symptoms do not improve within 7 days or are accompanied by fever
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

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.

Directions

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not exceed recommended dosage
  • mL = milliliter

    •                      Age               Dose  
     adults & children
     12 years & over 
    		 20 mL
    every 4 hours
     children 6 to under
     12 years
    		 10 mL
    every 4 hours
     children under 6 years do not use



Other Information

  • each 10 mL contains: sodium 10 mg
  • store at 20-25°C (68-77°F)
  • measuring cup provided

Inactive Ingredients

anhydrous citric acid, artificial flavor, FD&C blue #1, FD&C Red #40, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

Principal Display Panel

CVS

Health ®

Compare to the active ingredients in Children's Dimetapp® Cold & Cough*

NDC 51316-578-03

Children's

Cold & Cough

BROMPHENIRAMIINE MALEATE

Antihistamine 

DEXTROMETHORPHAN HYDROBROMIDE

Cough Suppressant

PHENYLEPHRINE HYDROCHLORIDE

Nasal Decongestant

DM Liquid

  • Relieves nasal congestion;
    Stuffy nose; Runny nose;
    Sneezes
  • Soothes Cough
  • Calm allergy symptoms

    • Alcohol free

    6+ Years


    Grape Flavor

    Dosage Cup Included 


    4 FL OZ (118 mL)

     

    577-4-cvs.jpg (577 4 Cvs)

    577-4-cvs.jpg (577 4 Cvs)

            

    577-4-o-cvs.jpg (577 4 O Cvs)

    577-4-o-cvs.jpg (577 4 O Cvs)

     

     

        



* Please review the disclaimer below.