Drug Facts

Drug Facts

SPL v4

SPL

SPL Set ID 15950273-14c9-4a0b-bbb4-683048add722

Route

ORAL

Published

Effective Date 2021-02-18

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Dextromethorphan (20 mg) Guaifenesin (200 mg)

Inactive Ingredients

Anhydrous Citric Acid Carboxymethylcellulose Sodium, Unspecified Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Dextrose, Unspecified Form Polyethylene Glycol, Unspecified Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Sodium Gluconate Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance

Color: purple

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-05-12

Description

Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 200 mg

Purpose

Cough suppressant Expectorant

Medication Information

Warnings and Precautions

Warnings

Indications and 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

Purpose

Cough suppressant Expectorant

Dosage and 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

age	dose
children under 4 years	do not use
children 4 to under 6 years	5 ml every 4 hours
children 6 to under 12 years	10 ml every 4 hours
adults and children 12 years and over	20 ml every 4 hours

Description

Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 200 mg

Section 42229-5

Distributed by:

Pfizer, Madison, NJ 07940 USA

Section 44425-7

Other information

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

Section 50565-1

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

Section 50566-9

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.

Section 50570-1

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.

Section 51727-6

Inactive ingredients

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

Section 53413-1

Questions or comments?

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

Section 53414-9

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

Purposes

Cough suppressant

Expectorant

Active Ingredients (in Each 20 Ml)

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 200 mg

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

Principal Display Panel 118 Ml Bottle Label

Children's

Robitussin^®

AGES 4 & OVER

Cough & Chest

Congestion

DM

DEXTROMETHORPHAN HBr

(Cough Suppressant)

GUAIFENESIN (Expectorant)

Alcohol-Free

4 FL OZ (118 ml)

Principal Display Panel 118 Ml Bottle Carton

Children's

Robitussin^®

FOR AGES 4 & OVER

Cough & Chest

Congestion

DM

DEXTROMETHORPHAN HBr

(Cough Suppressant)

GUAIFENESIN (Expectorant)

Relieves:

1.
Chest Congestion/Mucus
2.
Cough

Non-Drowsy

BETTER

TASTING!*

Great Grape Taste

grape flavor

4 FL OZ

(118 ml)

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

age	dose
children under 4 years	do not use
children 4 to under 6 years	5 ml every 4 hours
children 6 to under 12 years	10 ml every 4 hours
adults and children 12 years and over	20 ml every 4 hours

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 20 ml contains: sodium 20 mg
•
store at 20–25°C (68–77°F). Do not refrigerate.

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.

Section 50566-9 (50566-9)

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.

Section 50570-1 (50570-1)

Section 51727-6 (51727-6)

Inactive ingredients

Section 53413-1 (53413-1)

Questions or comments?

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

Section 53414-9 (53414-9)

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

Purposes

Cough suppressant

Expectorant

Active Ingredients (in Each 20 Ml) (Active ingredients (in each 20 ml))

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 200 mg

Ask A Doctor Before Use If You Have (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

Principal Display Panel 118 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label)

Children's

Robitussin^®

AGES 4 & OVER

Cough & Chest

Congestion

DM

DEXTROMETHORPHAN HBr

(Cough Suppressant)

GUAIFENESIN (Expectorant)

Alcohol-Free

4 FL OZ (118 ml)

Principal Display Panel 118 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton)

Children's

Robitussin^®

FOR AGES 4 & OVER

Cough & Chest

Congestion

DM

DEXTROMETHORPHAN HBr

(Cough Suppressant)

GUAIFENESIN (Expectorant)

Relieves:

1.
Chest Congestion/Mucus
2.
Cough

Non-Drowsy

BETTER

TASTING!*

Great Grape Taste

grape flavor

4 FL OZ

(118 ml)

Advanced Ingredient Data

[{"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "20", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "200", "strengthDenominator": "20", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROSE, UNSPECIFIED FORM", "unii": "IY9XDZ35W2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE, UNSPECIFIED FORM", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM GLUCONATE", "unii": "R6Q3791S76", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "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", "34068-7": "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 age dose children under 4 years do not use children 4 to under 6 years 5 ml every 4 hours children 6 to under 12 years 10 ml every 4 hours adults and children 12 years and over 20 ml every 4 hours", "34071-1": "Warnings", "42229-5": "Distributed by: Pfizer, Madison, NJ 07940 USA", "44425-7": "Other information • each 20 ml contains: sodium 20 mg • store at 20–25°C (68–77°F). Do not refrigerate.", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50566-9": "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.", "50570-1": "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.", "51727-6": "Inactive ingredients anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, FD&C red no. 40, glycerin, liquid glucose, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum", "53413-1": "Questions or comments? call weekdays from 9 AM to 5 PM EST at 1-800-762-4675", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purposes": "Cough suppressant Expectorant", "Active ingredients (in each 20 ml)": "Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 200 mg", "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", "PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label": "Children's Robitussin ® AGES 4 & OVER Cough & Chest Congestion DM DEXTROMETHORPHAN HBr (Cough Suppressant) GUAIFENESIN (Expectorant) Alcohol-Free 4 FL OZ (118 ml)", "PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton": "Children's Robitussin ® FOR AGES 4 & OVER Cough & Chest Congestion DM DEXTROMETHORPHAN HBr (Cough Suppressant) GUAIFENESIN (Expectorant) Relieves: 1. Chest Congestion/Mucus 2. Cough Non-Drowsy BETTER TASTING!* Great Grape Taste grape flavor 4 FL OZ (118 ml)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:46.955468 · Updated: 2026-03-14T23:02:29.359860