Childrens Mucus And Cough Relief Liquid
FDA Label NDC 51316-552

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 Mucus And Cough Relief (NDC 51316-552). 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 ingredients (in each 5 ml), purpose, uses, warning, do not use, ask a doctor before use if the child has, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each 5 Ml)

Dextromethorphan HBr 5 mg
Guaifenesin 100 mg

Purpose

Cough suppressant
Expectorant

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • temporarily relieves:
    •       cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
    •       the impulse to cough to help your child get to sleep 
    •       the intensity of coughing

Warning

.

Do Not Use

in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.


Ask A Doctor Before Use If The Child Has

  • persistent or chronic cough such as occurs with asthma 
  • cough that occurs with too much phlegm (mucus)

Stop Use And Ask A Doctor If

  •  cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious illness. 

Keep Out Of Reach Of Children

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup with other products
  • mL=milliliter


    •                          Age 
           Dose
     children 6 years to under 12 years 5 mL-10 mL
     every 4 hours
     children 4 years to under 6 years 2.5 mL - 5 mL
     every 4 hours
     children under 4 years do not use




Other Information

  • each 5 mL contains: potassium 5 mg, sodium 5 mg
  • store between 20 to 25°C (68 to 77°F)
  • do not refrigerate
  • dosing cup provided

Inactive Ingredients

citric acid anhydrous, dextrose, D&C red#33, FD&C red#40, flavor, glycerin, methylparaben, potassium sorbate, propylene glycol, propyl paraben, purified water, saccharin sodium, sodium hydroxide, sorbitol, sucralose, xanthan gum

Principal Display Panel

CVS Health

Compare to the active ingredients in Children's Mucinex® Cough*

NDC 51316-552-03

Children's

Cough 

 Dextromethorphan HBr 5mg

cough Suppressant 

Guaifenesin 100 mg

Expectorant 


Controls Cough

Relieves Chest Congestion

Breaks up mucus


Free of alcohol, parabens
& high fructose corn syrup


Ages 4+ Years


Natural Cherry Flavor

Dosage Cup Included

4 FL OZ (118mL)


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552-cvs.jpg (552 Cvs)


552-cvs-o.jpg (552 Cvs O)

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* Please review the disclaimer below.