Drug Facts

Drug Facts

SPL v5

SPL

SPL Set ID 8c821671-dc68-4e27-aa87-b4e45ade9817

Route

ORAL

Published

Effective Date 2025-01-14

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

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

Inactive Ingredients

Acesulfame Potassium Anhydrous Citric Acid Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Maltitol Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-12-01

Description

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Purpose

Pain reliever/Fever reducer Cough suppressant Expectorant

Medication Information

Purpose

Pain reliever/Fever reducer Cough suppressant Expectorant

Description

Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Uses

temporarily relieves these symptoms due to a cold:
- minor aches and pains
- minor sore throat pain
- headache
- cough due to minor throat and bronchial irritation
temporarily reduces fever
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Purposes

Pain reliever/Fever reducer

Cough suppressant

Expectorant

Warnings

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

more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

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.

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

Directions

do not use more than directed
measure the dose correctly using the enclosed dosing cup
take every 4 hours in dosing cup provided, while symptoms persist
do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor

Age	Dose
Adults and children 12 years of age and over	30 mL
Children under 12 years of age	do not use

Do Not Use

in a child under 12 years of age
if you are allergic to acetaminophen
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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.

Generic Section

Distributed by: Haleon, Warren, NJ 07059 Made in Mexico

Trademarks are owned by or licensed to the Haleon group of companies.

PEEL BACK HERE

DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING.

Other Information

each 30 mL contains: potassium 30 mg, sodium 13 mg
store at controlled room temperature 20°-25°C (68°-77°F)

Inactive Ingredients

acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, glycerin, maltitol solution, natural and artificial flavors, propylene glycol, purified water, sodium benzoate, sodium citrate

Questions Or Comments?

1-855-328-5259

Stop Use and Ask A Doctor If

fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
pain or cough gets worse or lasts more than 7 days
cough comes back or occurs with rash or headache that lasts

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 right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredients (in Each 30 Ml)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Ask A Doctor Before Use If You Have

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

Package/label Principal Display Panel

MULTI-SYMPTOM COLD RELIEF

THERAFLU

SEVERE

COLD RELIEF

+ CHEST CONFESTION

Acetaminophen

Pain reliever/Fever Reducer

Dextromethorphan HBr

Cough Suppressant

Guaifenesin/ Expectorant

DAYTIME FORMULA

Powerful formula that relieves:

/ Chest congestion

/ Thins and loosens mucus

/ Head and body ache

/ Fever

/ Cough

/ Sore throat pain

8.3 FL OZ (245.5 mL)

Berry Flavor

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin

Structured Label Content

Uses

temporarily relieves these symptoms due to a cold:
- minor aches and pains
- minor sore throat pain
- headache
- cough due to minor throat and bronchial irritation
temporarily reduces fever
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Purposes

Pain reliever/Fever reducer

Cough suppressant

Expectorant

Warnings

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

more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

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.

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

Directions

do not use more than directed
measure the dose correctly using the enclosed dosing cup
take every 4 hours in dosing cup provided, while symptoms persist
do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor

Age	Dose
Adults and children 12 years of age and over	30 mL
Children under 12 years of age	do not use

Do Not Use (Do not use)

in a child under 12 years of age
if you are allergic to acetaminophen
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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.

Generic Section

Distributed by: Haleon, Warren, NJ 07059 Made in Mexico

Trademarks are owned by or licensed to the Haleon group of companies.

PEEL BACK HERE

DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING.

Other Information (Other information)

each 30 mL contains: potassium 30 mg, sodium 13 mg
store at controlled room temperature 20°-25°C (68°-77°F)

Inactive Ingredients (Inactive ingredients)

Questions Or Comments? (Questions or comments?)

1-855-328-5259

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

fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
pain or cough gets worse or lasts more than 7 days
cough comes back or occurs with rash or headache that lasts

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.)

Active Ingredients (in Each 30 Ml) (Active ingredients (in each 30 mL))

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

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

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

Package/label Principal Display Panel (Package/Label Principal Display Panel)

MULTI-SYMPTOM COLD RELIEF

THERAFLU

SEVERE

COLD RELIEF

+ CHEST CONFESTION

Acetaminophen

Pain reliever/Fever Reducer

Dextromethorphan HBr

Cough Suppressant

Guaifenesin/ Expectorant

DAYTIME FORMULA

Powerful formula that relieves:

/ Chest congestion

/ Thins and loosens mucus

/ Head and body ache

/ Fever

/ Cough

/ Sore throat pain

8.3 FL OZ (245.5 mL)

Berry Flavor

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

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

taking the blood thinning drug warfarin

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache cough due to minor throat and bronchial irritation temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive", "Purposes": "Pain reliever/Fever reducer Cough suppressant Expectorant", "Warnings": "Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product 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. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by a fever, headache, rash, nausea, or vomiting consult a doctor promptly.", "Directions": "do not use more than directed measure the dose correctly using the enclosed dosing cup take every 4 hours in dosing cup provided, while symptoms persist do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor Age Dose Adults and children 12 years of age and over 30 mL Children under 12 years of age do not use", "Do not use": "in a child under 12 years of age if you are allergic to acetaminophen with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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.", "Generic Section": "Distributed by: Haleon, Warren, NJ 07059 Made in Mexico Trademarks are owned by or licensed to the Haleon group of companies. ©2024 Haleon group of companies or its licensor. Pat. Info www.productpats.com PEEL BACK HERE DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING.", "Other information": "each 30 mL contains: potassium 30 mg, sodium 13 mg store at controlled room temperature 20°-25°C (68°-77°F)", "Inactive ingredients": "acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, glycerin, maltitol solution, natural and artificial flavors, propylene glycol, purified water, sodium benzoate, sodium citrate", "Questions or comments?": "1-855-328-5259", "Stop use and ask a doctor if": "fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur pain or cough gets worse or lasts more than 7 days cough comes back or occurs with rash or headache that lasts 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 right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "Active ingredients (in each 30 mL)": "Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg", "Ask a doctor before use if you have": "liver disease cough that occurs with too much phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema", "Package/Label Principal Display Panel": "MULTI-SYMPTOM COLD RELIEF THERAFLU SEVERE COLD RELIEF + CHEST CONFESTION Acetaminophen Pain reliever/Fever Reducer Dextromethorphan HBr Cough Suppressant Guaifenesin / Expectorant DAYTIME FORMULA Powerful formula that relieves: / Chest congestion / Thins and loosens mucus / Head and body ache / Fever / Cough / Sore throat pain 8.3 FL OZ (245.5 mL) Berry Flavor PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org", "Ask a doctor or pharmacist before use if you are": "taking the blood thinning drug warfarin"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:07:13.143888 · Updated: 2026-03-14T23:10:28.026216