Robitussin Maximum Strength Nighttime Cough Dm Solution
FDA Label NDC 0031-8718

Full FDA labeling including 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 Maximum Strength Nighttime Cough Dm (NDC 0031-8718). 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 other, otc - purpose, uses, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

Distributed by:
Pfizer, Madison, NJ 07940 USA

Otc - Purpose

Active ingredients (in each 20 ml)Purposes
Dextromethorphan HBr, USP 30 mgCough suppressant
Doxylamine Succinate, USP 12.5 mgAntihistamine

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
    • controls the impulse to cough to help you sleep

Do Not Use

  • to sedate a child or to make a child sleepy
  • 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask A Doctor Before Use If You Have

  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When Using This Product

  • do not use more than directed
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Otc - Stop Use

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.

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.

Directions

  • measure only with dosing cup provided
  • keep dosing cup with product
  • ml = milliliter
  • do not take more than 4 doses in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age
  • agedose
    adults and children 12 years and over20 ml every 6 hours
    children under 12 yearsdo not use

Other Information

  • each 20 ml contains: sodium 14 mg
  • store at 20-25°C (68-77°F)

Inactive Ingredients

anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, FD&C red no. 40, glycerin, liquid glucose, menthol, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, triacetin, xanthan gum

Questions Or Comments?

call weekdays from 9 AM to 5 PM EST at 1-800-762-4675

Made in Canada

For most recent product information, visit www.robitussin.com

Principal Display Panel - 118 Ml Bottle Label

ADULT

Robitussin®

MAXIMUM STRENGTH

Nighttime
Cough DM

DM
NIGHTTIME
MAX

DEXTROMETHORPHAN HBr (Cough Suppressant)
DOXYLAMINE SUCCINATE (Antihistamine)

4 FL OZ (118 ml)

Principal Display Panel - 118 Ml Bottle Carton

See
New
Dosing

ADULT

Robitussin®

MAXIMUM STRENGTH

Nighttime
Cough DM

DEXTROMETHORPHAN HBr (Cough Suppressant)
DOXYLAMINE SUCCINATE (Antihistamine)

  • ✓Controls Cough
  • ✓Relieves Runny Nose
    & Sneezing
  • DM
    NIGHTTIME
    MAX

    BETTER
    TASTING!

    Same Effective
    Nighttime Relief*

    For Ages 12 & Over
    4 FL OZ (118 ml)

* Please review the disclaimer below.