Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID 5d12a1b8-f1fb-41ca-9a4f-0595a585cbb5
Route
ORAL
Published
Effective Date 2020-10-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (30 mg)
Inactive Ingredients
Polistirex D&c Red No. 30 D&c Yellow No. 10 Glycerin High Fructose Corn Syrup Methylparaben Polysorbate 80 Polyvinyl Acetate Povidone, Unspecified Propylparaben Sodium Metabisulfite Sodium Polystyrene Sulfonate Sucrose Tartaric Acid Tragacanth Triacetin Water Xanthan Gum Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Color: orange Color: purple
Marketing Status
ANDA Active Since 2016-07-05
Description

Active ingredient (in each 5 mL) Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide, USP

Medication Information

Warnings and Precautions

Warnings

Indications and 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
Dosage and 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
Description

Active ingredient (in each 5 mL) Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide, USP

Section 42229-5

Distributed by: Pfizer, Madison, NJ 07940 USA

Section 44425-7

Other information

  • each 5 mL contains: sodium 5 mg
  • store at 20-25°C (68-77°F)
  • dosing cup provided
Section 50565-1

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.

Section 50570-1

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.

Section 51727-6

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

Section 53413-1

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

Section 53414-9

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

Section 55105-1

Purpose

Cough suppressant

Section 55106-9

Active ingredient (in each 5 mL)

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide, USP

Allergy Alert

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

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

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.
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)

Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

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
Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Distributed by: Pfizer, Madison, NJ 07940 USA

Section 44425-7 (44425-7)

Other information

  • each 5 mL contains: sodium 5 mg
  • store at 20-25°C (68-77°F)
  • dosing cup provided
Section 50565-1 (50565-1)

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.

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

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

Section 53413-1 (53413-1)

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Cough suppressant

Section 55106-9 (55106-9)

Active ingredient (in each 5 mL)

Dextromethorphan polistirex equivalent to 30 mg dextromethorphan hydrobromide, USP

Allergy Alert

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

Principal Display Panel (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

Stop Use and Ask A Doctor If (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.
Ask A Doctor Before Use If You Have (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)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:56.922172 · Updated: 2026-03-14T23:02:46.668637