Childrens Cough Mucus Relief Liquid
FDA Label NDC 53943-512

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Discount Drug Mart for the product Childrens Cough Mucus Relief (NDC 53943-512). 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 drug factsactive ingredients(in each 5 ml teaspoonful), purpose, uses, warnings, ask a doctor before use if the child has, when using this product, 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

Drug Factsactive Ingredients(In Each 5 Ml Teaspoonful)

Dextromethorphan HBr, USP 5 mg
Guaifenesin, USP 100 mg

Purpose

Cough suppressant
Expectorant

Uses

  • temporarily relieves: cough due to minor throat and bronchial irritation as may occur with a cold
  • helps 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 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

  • cough that occurs with too much phlegm (mucus)
  • persistant 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 persistant  headache.

    • These could be signs of a serious condition.

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

Directions

  • do not take more than 6 doses in any 24-hour period

    • age                                                                   dose

    Children 6 years to 12 years                               1 to 2 teaspoonfuls (tsps) every 4 hours
    Children 4 years to under 6 years                        1/2 to 1 teaspoonful (tsps) every 4 hours
    Children under 4 years                                         do not use

Other Information

  • each teaspoonful contains sodium 3 mg
  • store between20-25°C (68-77°F)
  • do not refrigerate
  • dosing cup provided
  • Keep carton for full direction for use

Inactive Ingredients

anhydrous citric acid, dextrose, D&C red #33, FD&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

Children's Cough Mucus Relief Product Label

DISCOUNT
drug
mart
FOOD FAIR

DO NOT USE IF PRINTED SEAL, UNDER CAP IS TORN OR MISSING

COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN'S MUCINEX® COUGH*

Children's Cough Mucus Relief

Cough Suppressent

Expectorant

Dextromethorphan HBr 5 mg

Guaifensin 100 mg

Relieves Chest Congestion

Thins & Loosens Mucus

Alcohol free
for ages 4 to 12

CHERRY FLAVOR

4 FL OX (118 ml)

* this product is not manufactured or distributed by Reckitt Benckiser Inc., the distributer of Childrens Mucinex® Cough.

SATISFACTION GUARANTEED

IF DISSATISFIED, RETURN THE UNUSED PORTION AND PACKAGE TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STOORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS, AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINA, OHIO 44256

BX-052

* Please review the disclaimer below.