Robitussin Kit
FDA Label NDC 0031-2103

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 (NDC 0031-2103). 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)– robitussin maximum strength cough+chest congestion dm, purposes– robitussin maximum strength cough+chest congestion dm, uses– robitussin maximum strength cough+chest congestion dm, 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.

Label Section Quick Index

Active Ingredients (In Each 20 Ml)– Robitussin Maximum Strength Cough+Chest Congestion Dm

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 400 mg

Purposes– Robitussin Maximum Strength Cough+Chest Congestion Dm

Cough suppressant

Expectorant

Uses– Robitussin Maximum Strength Cough+Chest Congestion Dm

  • 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

  • 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

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

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.

cough lasts more than 7 days, comes back, or is accompanied by a fever, rash, or persistent headache.

These could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

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.

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

Directions– Robitussin Maximum Strength Cough+Chest Congestion Dm

  • 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

    • age

    dose

    adults and children 12 years and over

    20 mL every 4 hours

    children under 12 years

    do not use

Other Information– Robitussin Maximum Strength Cough+Chest Congestion Dm

  • each 20 mL contains:sodium 13 mg
  • store at 20-25°C (68-77°F). Do not refrigerate.

Inactive Ingredients– Robitussin Maximum Strength Cough+Chest Congestion Dm

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?– Robitussin Maximum Strength Cough+Chest Congestion Dm

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

Active Ingredients (In Each 20 Ml)– Robitussin Maximum Strength Nighttime Cough Dm

Dextromethorphan HBr, USP 30 mg

Doxylamine succinate, USP 12.5 mg

Purposes– Robitussin Maximum Strength Nighttime Cough Dm

Cough suppressant

Antihistamine

Uses– Robitussin Maximum Strength Nighttime Cough Dm

  • 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

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

Directions– Robitussin Maximum Strength Nighttime Cough Dm

  • 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

    • age

    dose

    adults and children 12 years and over

    20 mL every 6 hours

    children under 12 years

    do not use

Other Information– Robitussin Maximum Strength Nighttime Cough Dm

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

Inactive Ingredients– Robitussin Maximum Strength Nighttime Cough Dm

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?– Robitussin Maximum Strength Nighttime Cough Dm

call weekdays from 9 AM to 5 PM EST at 1-800-245-1040

Additional Information– Robitussin Maximum Strength Day/Night Value Pack

TAMPER-EVIDENT INNER UNITS:

Do Not Use if Tamper-Evident feature on either bottle cap is broken or missing. See individual inner cartons and bottle labels for specific Tamper-Evident features.

Do not take both products within 6 hours of each other.

STRONG SOOTHING ACTION and fast, powerful cough relief

PARENTS: Learn about teen medicine abuse

www.StopMedicineAbuse.org

Principal Display Panel – Robitussin Maximum Strength Cough+Chest Congestion Dm

ADULT

Robitussin

MAXIMUM STRENGTH

Cough+Chest Congestion DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

GUAIFENESIN (Expectorant)

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

    • FAST, EFFECTIVEcough relief

    DMMAX

    For Ages 12 & Over

    4 FL OZ (118 mL)

Principal Display Panel – Robitussin Maximum Strength Nighttime Cough Dm

ADULT

Robitussin

MAXIMUM STRENGTH

Nighttime Cough DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

DOXYLAMINE SUCCINATE (Antihistamine)

  • Controls Cough
  • Relieves Runny Nose & Sneezing

    • FAST, EFFECTIVE cough relief

    DMNIGHTTIME MAX

    For Ages 12 & Over

    4 FL OZ (118 mL)

Principal Display Panel – Robitussin Maximum Strength Day/Night Value Pack

DAY&NIGHT VALUE PACK

ADULT

Robitussin

MAXIMUM STRENGTH

COUGH+CHEST CONGESTION DM

DEXTROMETHORPHAN HBr (Cough Suppressant)

GUAIFENESIN (Expectorant)

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

    • FAST, EFFECTIVEcough relief

    DMMAX

    For Ages 12 & Over

    4 FL OZ (118 mL)

    MAXIMUM STRENGTH

    Nighttime Cough DM

    DEXTROMETHORPHAN HBr (Cough Suppressant)

    DOXYLAMINE SUCCINATE (Antihistamine)

    • Controls Cough
    • Relieves Runny Nose & Sneezing

      • FAST, EFFECTIVEcough relief

      DMNIGHTTIME MAX

      For Ages 12 & Over

      4 FL OZ (118 mL)

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