Meijer Children Cough And Chest Congestion Dm Liquid
FDA Label NDC 79481-7470

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Meijer Distribution Inc for the product Meijer Children Cough And Chest Congestion Dm (NDC 79481-7470). 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 20 ml), purposes, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients (In Each 20 Ml)

Dextromethorphan HBr, USP 20 mg
Guaifenesin, USP 200 mg

Purposes

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 bronchial tubes

Do Not Use

If you are now 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 taking this product.

Ask A Doctor Before Use If You Have

  • ▪cough that occurs with too much phlegm (mucus)
  • ▪cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

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 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 at (1-800-222-1222).

Directions

  • ▪do not take more than 6 doses in any 24-hour period
  • ▪measure only with dosing cup provided
  • ▪keep dosing cup with product
  • ▪mL = milliliter
  •  Age

    Dose

    children under 4 years

    do not use

    children 4 to under 6 years

    5 mL every 4 hours

    children 6 to under 12 years

    10 mL every 4 hours

    adults and children 12 years and older

    20 mL every 4 hours

Other Information

  • ▪each 20 mL contains: sodium 10 mg
  • ▪Contains low sodium
  • ▪store at room temperature. Do not refrigerate.

Inactive Ingredients

anhydrous citric acid, carboxymethylcellulose sodium, edetate disodium, glycerin, flavor, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose, xanthan gum.

Questions Or Comments

1-866-467-2748

Package Label-Principal Display Panel - 4 Fl Oz (118 Ml Bottle)

COMPARE TO THE CHILDREN'S ROBITUSSIN® COUGH + CHEST CONGESTION DM ACTIVE INGREDIENTS*

NDC 79481-7470-8
Meijer  
CHILDREN'S

for ages 4 & over

COUGH+ CHESTCONGESTION DM

SUGAR FREE

DEXTROMETHORPHAN HBr - COUGH SUPPRESSANT
GUAIFENESIN - EXPECTORANT

Relieves:

Chest Congestion/ cough & mucus

GRAPE FLAVOR

Naturally & Artificially Flavored

4 FL OZ (118 mL)

TAMPER-EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

IMPORTANT: KEEP THIS CARTON FOR FUTURE REFERENCE ON FULL LABELING

*This product is not manufactured or distributed by Pfizer, the distributor of Children’s Robitussin® Cough & Chest Congestion DM.

DIST. BY:

MEIJER DISTRIBUTION, INC

GRAND RAPIDS, MI 49544

www.meijer.com

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* Please review the disclaimer below.