Drug Facts

Drug Facts

SPL v9

SPL

SPL Set ID 8c0a2424-e8ac-d91c-b46d-a5ee29f91936

Route

ORAL

Published

Effective Date 2022-12-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Dextromethorphan (10 mg) Guaifenesin (100 mg) Phenylephrine (5 mg)

Inactive Ingredients

Water Anhydrous Citric Acid Fd&c Red No. 40 Glycerin Menthol, Unspecified Form Propylene Glycol Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Sucralose

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH DRUG Active Since 2011-06-12

Description

Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 200 mg Phenylephrine HCl, USP 10 mg

Purpose

Cough suppressant Expectorant Nasal decongestant

Medication Information

Purpose

Cough suppressant Expectorant Nasal decongestant

Description

Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 200 mg Phenylephrine HCl, USP 10 mg

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
temporarily relieves these symptoms occurring with a cold:
- nasal congestion
- cough due to minor throat and bronchial irritation

Section 42229-5

Distributed by:

Pfizer, Madison, NJ 07940 USA

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 50567-7

When using this product do not use more than directed.

Section 50568-5

Ask a doctor or pharmacist before use if you aretaking any other oral nasal decongestant or stimulant.

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 53414-9

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

Purposes

Cough suppressant

Expectorant

Nasal decongestant

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
this adult product is not intended for use in children under 12 years of age

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

Other Information

each 10 ml contains:sodium 6 mg
store at 20-25°C (68-77°F). Do not refrigerate.

Inactive Ingredients

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

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

Principal Display Panel

ADULT

Robitussin ^®

PEAK COLD

Multi-Symptom

Cold

DEXTROMETHORPHAN HBr (Cough Suppressant)

GUAIFENESIN (Expectorant)

PHENYLEPHRINE HCl (Nasal Decongestant)

Relieves:

Cough
Nasal Congestion
Mucus

Non-Drowsy CF

For Ages 12 & Over

4 FL OZ

(118 ml)

Stop Use and Ask A Doctor If

you get nervous, dizzy, or sleepless
symptoms do not get better within 7 days or are accompanied by fever
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.

Active Ingredients (in Each 10 Ml)

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 200 mg

Phenylephrine HCl, USP 10 mg

Ask A Doctor Before Use If You Have

heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Structured Label Content

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
temporarily relieves these symptoms occurring with a cold:
- nasal congestion
- cough due to minor throat and bronchial irritation

Section 42229-5 (42229-5)

Distributed by:

Pfizer, Madison, NJ 07940 USA

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 50567-7 (50567-7)

When using this product do not use more than directed.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking any other oral nasal decongestant or stimulant.

Section 50570-1 (50570-1)

Section 53414-9 (53414-9)

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

Purposes

Cough suppressant

Expectorant

Nasal decongestant

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
this adult product is not intended for use in children under 12 years of age

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

Other Information (Other information)

each 10 ml contains:sodium 6 mg
store at 20-25°C (68-77°F). Do not refrigerate.

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

ADULT

Robitussin ^®

PEAK COLD

Multi-Symptom

Cold

DEXTROMETHORPHAN HBr (Cough Suppressant)

GUAIFENESIN (Expectorant)

PHENYLEPHRINE HCl (Nasal Decongestant)

Relieves:

Cough
Nasal Congestion
Mucus

Non-Drowsy CF

For Ages 12 & Over

4 FL OZ

(118 ml)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

you get nervous, dizzy, or sleepless
symptoms do not get better within 7 days or are accompanied by fever
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.

Active Ingredients (in Each 10 Ml) (Active ingredients (in each 10 ml))

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 200 mg

Phenylephrine HCl, USP 10 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "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": "MENTHOL, UNSPECIFIED FORM", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "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": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes temporarily relieves these symptoms occurring with a cold: nasal congestion cough due to minor throat and bronchial irritation", "42229-5": "Distributed by: Pfizer, Madison, NJ 07940 USA", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50567-7": "When using this product do not use more than directed.", "50568-5": "Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant.", "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.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purposes": "Cough suppressant Expectorant Nasal decongestant", "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 this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 10 ml every 4 hours children under 12 years do not use", "Other information": "each 10 ml contains: sodium 6 mg store at 20-25°C (68-77°F). Do not refrigerate.", "Inactive ingredients": "anhydrous citric acid, FD&C red no. 40, glycerin, menthol, natural & artificial flavor, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose", "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", "PRINCIPAL DISPLAY PANEL": "ADULT Robitussin ® PEAK COLD Multi-Symptom Cold DEXTROMETHORPHAN HBr (Cough Suppressant) GUAIFENESIN (Expectorant) PHENYLEPHRINE HCl (Nasal Decongestant) Relieves: Cough Nasal Congestion Mucus Non-Drowsy CF For Ages 12 & Over 4 FL OZ (118 ml)", "Stop use and ask a doctor if": "you get nervous, dizzy, or sleepless symptoms do not get better within 7 days or are accompanied by fever 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.", "Active ingredients (in each 10 ml)": "Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 200 mg Phenylephrine HCl, USP 10 mg", "Ask a doctor before use if you have": "heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:56.869162 · Updated: 2026-03-14T23:02:45.179164