Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID 1b7b5811-722e-4c4a-844d-c05fa5cfb2e5

Route

ORAL

Published

Effective Date 2024-03-21

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 2024-06-01

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

BEST CHOICE Adult Tussin Multi-Symptom Cold

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

Principal Display Panel

*Compare to the active ingredients in Robitussin® Peak Cold Multi-Symptom Cold CF

Adult Tussin Multi-Symptom Cold CF

Dextromethorphan HBr 20 mg

Cough Suppressant

Guaifenesin 200 mg

Expectorant

Phenylephrine HCl 10 mg

Nasal Decongestant

Relieves

Cough
Mucus
Nasal Congestion

For ages 12 years and over

Dosing Cup Included

Non-drowsy

Alcohol Free

FL OZ (mL)

*This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Robitussin® Peak Cold Multi-Symptom Cold CF.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

PROUDLY DISTRIBUTED BY:

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 (1800-222-122) 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
cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
cough that occurs with too much phlegm ( mucus)
trouble urinating due to enlarged prostate gland

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

BEST CHOICE Adult Tussin Multi-Symptom Cold

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

Principal Display Panel

*Compare to the active ingredients in Robitussin® Peak Cold Multi-Symptom Cold CF

Adult Tussin Multi-Symptom Cold CF

Dextromethorphan HBr 20 mg

Cough Suppressant

Guaifenesin 200 mg

Expectorant

Phenylephrine HCl 10 mg

Nasal Decongestant

Relieves

Cough
Mucus
Nasal Congestion

For ages 12 years and over

Dosing Cup Included

Non-drowsy

Alcohol Free

FL OZ (mL)

*This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Robitussin® Peak Cold Multi-Symptom Cold CF.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

PROUDLY DISTRIBUTED BY:

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 (1800-222-122) 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
cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
cough that occurs with too much phlegm ( mucus)
trouble urinating due to enlarged prostate gland

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 than 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 adults product is not intended for use in children under 12 years of age adult 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": "BEST CHOICE Adult Tussin Multi-Symptom Cold", "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", "Principal Display Panel": "*Compare to the active ingredients in Robitussin® Peak Cold Multi-Symptom Cold CF Adult Tussin Multi-Symptom Cold CF Dextromethorphan HBr 20 mg Cough Suppressant Guaifenesin 200 mg Expectorant Phenylephrine HCl 10 mg Nasal Decongestant Relieves Cough Mucus Nasal Congestion For ages 12 years and over Dosing Cup Included Non-drowsy Alcohol Free FL OZ (mL) *This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Robitussin® Peak Cold Multi-Symptom Cold CF. TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. PROUDLY DISTRIBUTED BY:", "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 (1800-222-122) 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 cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema cough that occurs with too much phlegm ( mucus) trouble urinating due to enlarged prostate gland", "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: 2026-02-15T12:03:07.819574 · Updated: 2026-03-14T23:03:01.087200