Drug Facts

Drug Facts

SPL v9

SPL

SPL Set ID 14c507df-fbac-4a09-a66c-b91c2abbf550

Route

ORAL

Published

Effective Date 2025-11-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Dextromethorphan (20 mg) Guaifenesin (200 mg) Phenylephrine (10 mg)

Inactive Ingredients

Anhydrous Citric Acid Glycerin Propylene Glycol Water Sodium Benzoate Fd&c Red No. 40 Lactic Acid Menthol Sorbitol Sucralose

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2017-01-31 Until 2026-01-01

Description

Dextromethorphan HBr 20 mg Guaifenesin 200 mg Phenylephrine HCl 10 mg

Purpose

Cough suppressant Expectorant Nasal decongestant

Medication Information

Purpose

Cough suppressant Expectorant Nasal decongestant

Description

Dextromethorphan HBr 20 mg Guaifenesin 200 mg Phenylephrine HCl 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

Purposes

Cough suppressant

Expectorant

Nasal decongestant

Directions

do not take more then 6 doses in any 24-hour period
measure only with dosing cup provided. Do not use any other dosing device.
keep dosing cup with product
mL=milliliter
this adult product is not intended for use in children under 12 years of age
adults and children 12 years and over: 10 mL every 4 hours
children under 12 years: 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.

Package Label

LEADER Adult Tussin Multi-Symptom Cold CF

Other Information

store between 20-25°C (68-77°F). Do not refrigerate.

Inactive Ingredients

anhydrous citric acid, FD&C red #40, flavor, glycerin, lactic acid, menthol, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO ROBITUSSIN® PEAK COLD MULTI-SYMPTOM COLD CF active ingredient*

Adult

Tussin Multi-Symptom Cold CF

Dextromethorphan HBr

Guaifenesin

Phenylephrine HCl

Cough Suppressant

Expectorant

Nasal decongestant

Ages 12 years and Over

Relieves:

Cough
Mucus
Nasal congestion

Alcohol-Free

FL OZ (mL)

Dosing Cup Included

*This product is not manufactured or distributed by Haleon group of companies, distributors of Robitussin® Peak Cold Multi-Symptom Cold CF.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPEN OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

When Using This Product,

do not use more than directed.

Stop Use and Ask A Doctor If

nervousness, dizziness, or sleeplessness occur
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.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredients (in Each 10 Ml)

Dextromethorphan HBr 20 mg

Guaifenesin 200 mg

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have

heart disease
diabetes
high blood pressure
thyroid disease
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

Ask A Doctor Or Pharmacist Before Use If You Are

taking any other oral nasal decongestant or stimulant.

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

Purposes

Cough suppressant

Expectorant

Nasal decongestant

Directions

do not take more then 6 doses in any 24-hour period
measure only with dosing cup provided. Do not use any other dosing device.
keep dosing cup with product
mL=milliliter
this adult product is not intended for use in children under 12 years of age
adults and children 12 years and over: 10 mL every 4 hours
children under 12 years: do not use

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.

Package Label

LEADER Adult Tussin Multi-Symptom Cold CF

Other Information (Other information)

store between 20-25°C (68-77°F). Do not refrigerate.

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, FD&C red #40, flavor, glycerin, lactic acid, menthol, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO ROBITUSSIN® PEAK COLD MULTI-SYMPTOM COLD CF active ingredient*

Adult

Tussin Multi-Symptom Cold CF

Dextromethorphan HBr

Guaifenesin

Phenylephrine HCl

Cough Suppressant

Expectorant

Nasal decongestant

Ages 12 years and Over

Relieves:

Cough
Mucus
Nasal congestion

Alcohol-Free

FL OZ (mL)

Dosing Cup Included

*This product is not manufactured or distributed by Haleon group of companies, distributors of Robitussin® Peak Cold Multi-Symptom Cold CF.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPEN OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

When Using This Product, (When using this product,)

do not use more than directed.

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

nervousness, dizziness, or sleeplessness occur
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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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 (1-800-222-1222) right away.

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

Dextromethorphan HBr 20 mg

Guaifenesin 200 mg

Phenylephrine HCl 10 mg

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

heart disease
diabetes
high blood pressure
thyroid disease
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

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking any other oral nasal decongestant or stimulant.

Advanced Ingredient Data

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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", "Purposes": "Cough suppressant Expectorant Nasal decongestant", "Directions": "do not take more then 6 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product mL=milliliter this adult product is not intended for use in children under 12 years of age adults and children 12 years and over: 10 mL every 4 hours children under 12 years: 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.", "Package Label": "LEADER Adult Tussin Multi-Symptom Cold CF", "Other information": "store between 20-25°C (68-77°F). Do not refrigerate.", "Inactive ingredients": "anhydrous citric acid, FD&C red #40, flavor, glycerin, lactic acid, menthol, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose", "Questions or comments?": "Call 1-877-753-3935 Monday-Friday 9AM-5PM EST", "Principal Display Panel": "COMPARE TO ROBITUSSIN® PEAK COLD MULTI-SYMPTOM COLD CF active ingredient* Adult Tussin Multi-Symptom Cold CF Dextromethorphan HBr Guaifenesin Phenylephrine HCl Cough Suppressant Expectorant Nasal decongestant Ages 12 years and Over Relieves: Cough Mucus Nasal congestion Alcohol-Free FL OZ (mL) Dosing Cup Included *This product is not manufactured or distributed by Haleon group of companies, distributors of Robitussin® Peak Cold Multi-Symptom Cold CF. TAMPER EVIDENT: DO NOT USE IF CARTON IS OPEN OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017", "When using this product,": "do not use more than directed.", "Stop use and ask a doctor if": "nervousness, dizziness, or sleeplessness occur 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.", "If pregnant or breast-feeding,": "ask a health professional before use.", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.", "Active ingredients (in each 10 mL)": "Dextromethorphan HBr 20 mg Guaifenesin 200 mg Phenylephrine HCl 10 mg", "Ask a doctor before use if you have": "heart disease diabetes high blood pressure thyroid disease 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", "Ask a doctor or pharmacist before use if you are": "taking any other oral nasal decongestant or stimulant. "}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:19.714061 · Updated: 2026-03-14T23:10:38.535907