Childrens Mucus Relief Cough
FDA Label NDC 68016-158

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Consortium, Llc for the product Childrens Mucus Relief Cough (NDC 68016-158). 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, purpose, keep out of reach of children, uses, warnings, ask a doctor before use if the child has, 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 Ingredients

Drug Facts

Active ingredients (in each 5 mL teaspoonful)

Dextromethorphan HBr 5 mg
Guaifenesin 100 mg

Purpose

Cough suppressant
Expectorant

Keep Out Of Reach Of Children

Keep out of reach of children.

 In case of overdose, get medical help or contact a Poison Control center right away.

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps to loosen phlegm (mucus) and thin bronchial secretions to drain the bronchial tubes

Warnings

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 two weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or a pharmacist before taking this product.

Ask A Doctor Before Use If The Child Has

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

When Using This Product

  • do not use more than directed

Stop Use And Ask A Doctor If

  • cough lasts more than 7 days, comes back or occurs with fever, rash, or persistent headache.
  • These could be signs of a serious condition.

Directions

  • do not take more than 6 doses in any 24-hour period
    • Aptapharmapv Childmucusrelief1 Label (Aptapharmapv Childmucusrelief1)

    Aptapharmapv Childmucusrelief1 Label (Aptapharmapv Childmucusrelief1)

Other Information

    each teaspoon contains: sodium 3 mg

  • store between 20-25 ° C (68-77° F)
  • do not refrigerate
  • dosage cup provided
  • Keep carton for full directions for use

Inactive Ingredients

citric acid anhydrous, dextrose, D and C Red # 33, FD and C Red # 40, flavors, glycerin, maltitol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sucralose, Xanthan gum

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST

1-877-798-5944

Product Label

NDC 68016-158-04
*COMPARE TO THE ACTIVE INGREDIENTS IN CHILDRENS MUCINEX® COUGH

Premier Value®

Childrens
Mucus Relief
COUGH

Dextromethorphan HBr ..... Cough Suppressant
Guaifenesin ..................... Expectorant


Relieves Chest Congestion
Thins and Loosens Mucus

Alcohol Free
For Ages 4 to 12

Cherry Flavor

 4 FL OZ (118mL)

INDEPENDENTLY TESTED SATISFACTION GUARANTEED PV
DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING
 

*This product is not manufactured or distributed by Reckitt Benckiser Inc. distributor of Mucinex® Cough

If for Any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

DISTRIBUTED BY
CHAIN DRUG CONSORTIUM
3301 NW BOCA RATON BLVD
SUITE 101, BOCA RATON, FL 33431


BX-015

Aptapharmapv Childmucusrelief Label (Aptapharmapv Childmucusrelief)

Aptapharmapv Childmucusrelief Label (Aptapharmapv Childmucusrelief)

* Please review the disclaimer below.