Cvs Maximum Strength Adult Severe Multi-symptom Cough Cold+flu Drug Facts

SPL v1

SPL

SPL Set ID cdc9af7c-3766-4573-9d95-bf217907b932

Route

ORAL

Published

Effective Date 2025-07-11

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (650 mg) Dextromethorphan (20 mg) Guaifenesin (400 mg)

Inactive Ingredients

Anhydrous Citric Acid Edetate Disodium Fd&c Red No. 40 Glycerin Potassium Citrate Propylene Glycol Propyl Gallate Water Sodium Benzoate Sorbitol Sucralose Xanthan Gum Menthol, Unspecified Form

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-06-23

Description

Acetaminophen, USP 650 mg Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 400 mg

Purpose

Pain reliever/Fever reducer Cough suppressant Expectorant

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

temporarily relieves these symptoms occurring with a cold or flu:
cough due to minor throat and bronchial irritation
minor aches and pains
sore throat
headache
temporarily reduces fever
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

Purpose

Pain reliever/Fever reducer Cough suppressant Expectorant

Dosage and Administration

Directions

do not take more than 6 doses in any 24-hour period
do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
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	20 ml every 4 hours
children under 12 years	do not use

Description

Acetaminophen, USP 650 mg Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 400 mg

Section 42229-5

Allergy alert:acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Section 44425-7

Other information

each 20 ml contains:sodium 7 mg
store at room temperature. 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 at 1-800-222-1222. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

Section 50566-9

Stop use and ask a doctor if

pain or cough gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

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 are

taking the blood thinning drug warfarin
taking any other pain reliever/fever reducer

Section 50569-3

Ask a doctor before use if you have

liver disease
cough that occurs with too much phlegm (mucus)
a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

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.
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Section 51727-6

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C red no. 40, glycerin, menthol, flavors, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Section 53413-1

Questions or comments?

1-866-467-2748

Section 53414-9

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

Purposes

Pain reliever/Fever reducer

Cough suppressant

Expectorant

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if you take

more than 6 doses in any 24-hour period, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Sore Throat Warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Principal Display Panel

Compare to the active ingredients in Adult Robitussin® Maximum Strength SEVERE Multi-Symptom Cough Cold + Flu CF MAX*

NDC 51316-089-08

MAXIMUM STRENGTH

Adult

SEVERE

Multi-Symptom

Cough Cold + Flu

ACETAMINOPHEN (Pain Reliever/Fever Reducer)

Dextromethorphan HBr (Cough Suppressant)

Guaifenesin (Expectorant)

Cough, Sore Throat
Head & Body Aches, Fever
Chest Congestion
Thins & Loosens Mucus

Sugar-Free

No Added Alcohol

Natural Raspberry Flavor

For Ages 12 & Over

8 FL OZ (237 ml)

IMPORTANT: Keep this carton for future reference for full labeling

TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

*This product is not manufactured or distributed by GSK Consumer Healthcare, Owner o the registered trademark Adult Robitussin Maximum Strength SEVERE Multi-Symptom Cough Cold + Flu CF MAX.

Active Ingredients (in Each 20 Ml)

Acetaminophen, USP 650 mg

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 400 mg

Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves these symptoms occurring with a cold or flu:
cough due to minor throat and bronchial irritation
minor aches and pains
sore throat
headache
temporarily reduces fever
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive

Dosage and Administration (34068-7)

Directions

do not take more than 6 doses in any 24-hour period
do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
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	20 ml every 4 hours
children under 12 years	do not use

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Allergy alert:acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Section 44425-7 (44425-7)

Other information

each 20 ml contains:sodium 7 mg
store at room temperature. Do not refrigerate.

Section 50565-1 (50565-1)

Section 50566-9 (50566-9)

Stop use and ask a doctor if

pain or cough gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

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 are

taking the blood thinning drug warfarin
taking any other pain reliever/fever reducer

Section 50569-3 (50569-3)

Ask a doctor before use if you have

liver disease
cough that occurs with too much phlegm (mucus)
a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

Section 50570-1 (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.
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Section 51727-6 (51727-6)

Inactive ingredients

Section 53413-1 (53413-1)

Questions or comments?

1-866-467-2748

Section 53414-9 (53414-9)

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

Purposes

Pain reliever/Fever reducer

Cough suppressant

Expectorant

Liver Warning (Liver warning)

This product contains acetaminophen. Severe liver damage may occur if you take

more than 6 doses in any 24-hour period, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Sore Throat Warning (Sore throat warning)

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Compare to the active ingredients in Adult Robitussin® Maximum Strength SEVERE Multi-Symptom Cough Cold + Flu CF MAX*

NDC 51316-089-08

MAXIMUM STRENGTH

Adult

SEVERE

Multi-Symptom

Cough Cold + Flu

ACETAMINOPHEN (Pain Reliever/Fever Reducer)

Dextromethorphan HBr (Cough Suppressant)

Guaifenesin (Expectorant)

Cough, Sore Throat
Head & Body Aches, Fever
Chest Congestion
Thins & Loosens Mucus

Sugar-Free

No Added Alcohol

Natural Raspberry Flavor

For Ages 12 & Over

8 FL OZ (237 ml)

IMPORTANT: Keep this carton for future reference for full labeling

TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

*This product is not manufactured or distributed by GSK Consumer Healthcare, Owner o the registered trademark Adult Robitussin Maximum Strength SEVERE Multi-Symptom Cough Cold + Flu CF MAX.

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

Acetaminophen, USP 650 mg

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 400 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses temporarily relieves these symptoms occurring with a cold or flu: cough due to minor throat and bronchial irritation minor aches and pains sore throat headache temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive", "34068-7": "Directions do not take more than 6 doses in any 24-hour period do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage. 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 20 ml every 4 hours children under 12 years do not use", "34071-1": "Warnings", "42229-5": "Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.", "44425-7": "Other information each 20 ml contains: sodium 7 mg store at room temperature. 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 at 1-800-222-1222. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.", "50566-9": "Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.", "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 the blood thinning drug warfarin taking any other pain reliever/fever reducer", "50569-3": "Ask a doctor before use if you have liver disease cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or 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. with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.", "51727-6": "Inactive ingredients anhydrous citric acid, edetate disodium, FD&C red no. 40, glycerin, menthol, flavors, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum", "53413-1": "Questions or comments? 1-866-467-2748", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purposes": "Pain reliever/Fever reducer Cough suppressant Expectorant", "Liver warning": "This product contains acetaminophen. Severe liver damage may occur if you take more than 6 doses in any 24-hour period, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product", "Sore throat warning": "If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.", "PRINCIPAL DISPLAY PANEL": "Compare to the active ingredients in Adult Robitussin® Maximum Strength SEVERE Multi-Symptom Cough Cold + Flu CF MAX* NDC 51316-089-08 MAXIMUM STRENGTH Adult SEVERE Multi-Symptom Cough Cold + Flu ACETAMINOPHEN (Pain Reliever/Fever Reducer) Dextromethorphan HBr (Cough Suppressant) Guaifenesin (Expectorant) Cough, Sore Throat Head & Body Aches, Fever Chest Congestion Thins & Loosens Mucus Sugar-Free No Added Alcohol Natural Raspberry Flavor For Ages 12 & Over 8 FL OZ (237 ml) IMPORTANT: Keep this carton for future reference for full labeling TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING *This product is not manufactured or distributed by GSK Consumer Healthcare, Owner o the registered trademark Adult Robitussin Maximum Strength SEVERE Multi-Symptom Cough Cold + Flu CF MAX.", "Active ingredients (in each 20 ml)": "Acetaminophen, USP 650 mg Dextromethorphan HBr, USP 20 mg Guaifenesin, USP 400 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:29.881670 · Updated: 2026-03-14T23:09:18.179019