Drug Facts

Drug Facts

SPL v10

SPL

SPL Set ID b9772292-9eb6-47cf-abb8-007c25478090

Route

ORAL

Published

Effective Date 2022-12-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Dextromethorphan (5 mg) Guaifenesin (100 mg)

Inactive Ingredients

Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Polyethylene Glycol, Unspecified Propylene Glycol, (r)- Water Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Sucralose

Identifiers & Packaging

Pill Appearance

Color: purple

Marketing Status

OTC MONOGRAPH DRUG Active Since 2014-07-01

Description

Dextromethorphan HBr, USP 5 mg Guaifenesin, USP 100 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

measure only with dosing cup provided
keep dosing cup with product
ml = milliliter
do not take more than 6 doses in any 24-hour period

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 5 mg Guaifenesin, USP 100 mg

Section 42229-5

Distributed by:

Pfizer, Madison, NJ 07940 USA

Section 44425-7

Other information

each 5 ml contains:sodium 3 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 ifcough 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 50569-3

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

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

anhydrous citric acid, artificial flavor, FD&C blue no. 1, FD&C red no. 40, glycerin, natural flavor, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Section 53413-1

Questions or comments?

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

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

Section 53414-9

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

Purposes

Cough suppressant

Expectorant

Principal Display Panel

NEW

Dosing

Information

Children's

Robitussin ^®

NOW FOR AGES 4 & OVER

Cough & Chest

Congestion

DEXTROMETHORPHAN HBr

(Cough Suppressant)

GUAIFENESIN (Expectorant)

Relieves:

✓ Chest Congestion/Mucus

✓ Cough

Non-Drowsy

grape

flavor

4 FL OZ

(118 ml)

Active Ingredients (in Each 5 Ml)

Dextromethorphan HBr, USP 5 mg

Guaifenesin, USP 100 mg

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

measure only with dosing cup provided
keep dosing cup with product
ml = milliliter
do not take more than 6 doses in any 24-hour period

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 5 ml contains:sodium 3 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 ifcough 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 50569-3 (50569-3)

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

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

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.

Purposes

Cough suppressant

Expectorant

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NEW

Dosing

Information

Children's

Robitussin ^®

NOW FOR AGES 4 & OVER

Cough & Chest

Congestion

DEXTROMETHORPHAN HBr

(Cough Suppressant)

GUAIFENESIN (Expectorant)

Relieves:

✓ Chest Congestion/Mucus

✓ Cough

Non-Drowsy

grape

flavor

4 FL OZ

(118 ml)

Active Ingredients (in Each 5 Ml) (Active ingredients (in each 5 ml))

Dextromethorphan HBr, USP 5 mg

Guaifenesin, USP 100 mg

Advanced Ingredient Data

[{"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "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": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL, (R)-", "unii": "602HN5L69H", "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": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

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 measure only with dosing cup provided keep dosing cup with product ml = milliliter do not take more than 6 doses in any 24-hour period 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 5 ml contains: sodium 3 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.", "50569-3": "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", "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, artificial flavor, FD&C blue no. 1, FD&C red no. 40, glycerin, natural flavor, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose", "53413-1": "Questions or comments? call weekdays from 9 AM to 5 PM EST at 1-800-762-4675 For most recent product information, visit www.robitussin.com", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purposes": "Cough suppressant Expectorant", "PRINCIPAL DISPLAY PANEL": "NEW Dosing Information Children's Robitussin ® NOW FOR AGES 4 & OVER Cough & Chest Congestion DM DEXTROMETHORPHAN HBr (Cough Suppressant) GUAIFENESIN (Expectorant) Relieves: ✓ Chest Congestion/Mucus ✓ Cough Non-Drowsy grape flavor 4 FL OZ (118 ml)", "Active ingredients (in each 5 ml)": "Dextromethorphan HBr, USP 5 mg Guaifenesin, USP 100 mg"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:52.780309 · Updated: 2026-03-14T23:02:39.250584