Robitussin Elderberry Maximum Strength Cough Plus Chest Congestion Dm Solution
FDA Label NDC 0031-2097

15 label sections · Submitted to the FDA by Haleon Us Holdings Llc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Robitussin Elderberry Maximum Strength Cough Plus Chest Congestion Dm (NDC 0031-2097). 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, indications & usage, warnings, otc - do not use, ask a doctor before use if you have, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each 20 Ml)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Purposes

Cough suppressant

Expectorant

Indications & Usage

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

Warnings

Warnings

Otc - Do Not Use

Do not useif 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 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

Otc - Stop Use

Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.
These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding,ask a health professional before use.

Otc - 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.

Dosage & Administration

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
  • this adult product is not intended for use in children under 12 years of age
    • agedose

    adults and children

    12 years and over

    20 mL every 4 hours

    children under 12 years

    do not use

Storage And Handling

Other information

  • each 20 mL contains:potassium 5 mg, sodium 21 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.

Inactive Ingredient

Inactive ingredients

anhydrous citric acid, black elderberry juice concentrate (for flavor), carboxymethylcellulose sodium, glycerin, liquid glucose, maltodextrin, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum, zinc gluconate

Otc - Questions

Questions or comments?

call weekdays from 8 AM to 6 PM EST at 1-800-245-1040

Additional Information

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Packaged with Tamper-Evident bottle cap.

Do Not Use if breakable ring is separated or missing.

Principal Display Panel

ADULT

Robitussin

Elderberry

Cough+Chest
Congestion DM

DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)

MAXIMUM STRENGTH

  • Controls Cough
  • Relieves Chest Congestion
  • Thins & Loosens Mucus

    • Taste the
    Real Elderberry

    DM
    MAX

    For Ages 12+
    4 FL OZ (118 mL)

* Please review the disclaimer below.