Robitussin 12 Hour Cough Relief Suspension, Extended Release
FDA Label NDC 0031-8754

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 12 Hour Cough Relief (NDC 0031-8754). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, allergy alert, ask a doctor before use if you have, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient (in each 5 mL)

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide, USP

Otc - Purpose

Purpose

Cough suppressant

Indications & Usage

Uses

temporarily relieves

  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • the impulse to cough to help you get to sleep

Warnings

Warnings

Otc - Do Not Use

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.

Allergy Alert

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions.

Ask A Doctor Before Use If You Have

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

Stop Use And Ask A Doctor If

  • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
  • cough lasts more than 7 days, cough comes back, or occurs with fever, rash, or headache that lasts. 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 1-800-222-1222.

Dosage & Administration

Directions

  • shake bottle well before use
  • measure only with dosing cup provided. Do not use dosing cup with other products
  • dose as follows or as directed by doctor
  • mL = milliliter

    • adults and children 12 years of age and over

    10 mL every 12 hours, not to exceed 20 mL in 24 hours

    children 6 to under 12 years of age

    5 mL every 12 hours, not to exceed 10 mL in 24 hours

    children 4 to under 6 years of age

    2.5 mL every 12 hours, not to exceed 5 mL in 24 hours

    children under 4 years of age

    do not use

Storage And Handling

Other information

  • each 5 mL contains: sodium 5 mg
  • store at 20-25°C (68-77°F)
  • dosing cup provided

Inactive Ingredient

Inactive ingredients (Grape flavor)

D&C red no. 30, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum

Inactive ingredients (Orange flavor)

D&C red no. 30, D&C yellow no. 10, flavor, glycerin, high fructose corn syrup, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum

Otc - Questions

Questions?

call weekdays from 9 AM to 5 PM EST at 1-800-762-4675.
You may also report side effects to this number.

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

Other

Distributed by: Pfizer, Madison, NJ 07940 USA

Principal Display Panel

Robitussin®

EXTENDED-RELEASE
12 Hour
Cough Relief

DEXTROMETHORPHAN POLISTIREX EXTENDED-
RELEASE ORAL SUSPENSION (Cough Suppressant)

12 Hour
Cough Relief

DAY or NIGHT

Orange
Flavored Liquid

Alcohol-Free

3 FL OZ (89 mL)

Contains sodium metabisulfite, a sulfite
that may cause allergic-type reactions

Robitussin 12 Hr Orange 3 Fl Oz(89 mL) (Image 01)

Robitussin 12 Hr Orange 3 Fl Oz(89 mL) (Image 01)

NEW SIZE!

Robitussin®

EXTENDED-RELEASE
12 Hour
Cough Relief

DEXTROMETHORPHAN POLISTIREX EXTENDED-
RELEASE ORAL SUSPENSION (Cough Suppressant)

12 Hour
Cough Relief

DAY or NIGHT

Orange
Flavored Liquid

Alcohol-Free

5 FL OZ
(148 mL)

Contains sodium metabisulfite, a sulfite
that may cause allergic-type reactions

Robitussin 12 Hr Orange 5 Fl Oz (148 mL) (Image 02)

Robitussin 12 Hr Orange 5 Fl Oz (148 mL) (Image 02)

Robitussin®

EXTENDED-RELEASE
12 Hour
Cough Relief

DEXTROMETHORPHAN POLISTIREX EXTENDED-
RELEASE ORAL SUSPENSION (Cough Suppressant)

12 Hour
Cough Relief

DAY or NIGHT

Grape
Flavored Liquid

Alcohol-Free

3 FL OZ (89 mL)

Contains sodium metabisulfite, a sulfite
that may cause allergic-type reactions

Robitussin 12 Hr Grape 3 Fl Oz (89 mL) (Image 03)

Robitussin 12 Hr Grape 3 Fl Oz (89 mL) (Image 03)

NEW SIZE!

Robitussin®

EXTENDED-RELEASE
12 Hour
Cough Relief

DEXTROMETHORPHAN POLISTIREX EXTENDED-
RELEASE ORAL SUSPENSION (Cough Suppressant)

12 Hour
Cough Relief

DAY or NIGHT

Grape
Flavored Liquid

Alcohol-Free

5 FL OZ
(148 mL)

Contains sodium metabisulfite, a sulfite
that may cause allergic-type reactions

Robitussin 12 Hr Grape 5 Fl Oz (148 mL) (Image 04)

Robitussin 12 Hr Grape 5 Fl Oz (148 mL) (Image 04)

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