Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID b01cc9f5-53f2-40d8-acf1-6de180b3d0bf
Route
ORAL
Published
Effective Date 2024-10-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (20 mg) Guaifenesin (400 mg) Diphenhydramine (25 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 2024-02-01

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 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.
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

Additional Information

DO NOT TAKE THE DAYTIME AND NIGHTTIME PRODUCTS AT THE SAME TIME. DO NOT TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.

DO NOT TAKE A DOSE OF THE NIGHTTIME PRODUCT SOONER THAN 4 HOURS AFTER THE LAST DOSE OF THE DAYTIME PRODUCT UNLESS DIRECTED BY YOUR DOCTOR.

DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME OR TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

TAMPER-EVIDENT INNER UNIT. DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING.

*Temporarily controls cough to help you rest. This is not a sleep aid.

Questions Or Comments?

1-855-328-5259

When Using This Product
  • avoid alcoholic drinks
  • marked drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
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
Principal Display Panel (day/night Combination)

MULTI-SYMPTOM COLD RELIEF

NEW FORMULA

VALUE PACK

DAYTIME FORMULA

SEVERE COLD RELIEF

MULTI-SYMPTOM COLD RELIEF

NEW FORMULA

THERAFLU

SEVERE COLD RELIEF + CHEST CONGESTION

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

SEVERE COLD RELIEF

HELPS YOU REST*

MULTI-SYMPTOM COLD RELIEF

NEW FORMULA

THERAFLU

SEVERE COLD RELIEF NIGHTTIME

Acetaminophen

Pain Reliever/Fever Reducer

Diphenhydramine HCl

Antihistamine/Cough Suppressant

HELPS YOU REST*

Powerful formula that relieves:

/ Cough

/ Sore throat pain

/ Head and body ache

/ Fever

/ Runny nose

/ Sneezing

8.3 FL OZ (245.5 mL) Berry Flavor

2-8.3 FL OZ (245.5 mL) BOTTLES TOTAL 16.6 FL OZ (491 mL)

USE ONLY AS DIRECTED

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 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.
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)

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

Additional Information

DO NOT TAKE THE DAYTIME AND NIGHTTIME PRODUCTS AT THE SAME TIME. DO NOT TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.

DO NOT TAKE A DOSE OF THE NIGHTTIME PRODUCT SOONER THAN 4 HOURS AFTER THE LAST DOSE OF THE DAYTIME PRODUCT UNLESS DIRECTED BY YOUR DOCTOR.

DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME OR TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

TAMPER-EVIDENT INNER UNIT. DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR MISSING.

*Temporarily controls cough to help you rest. This is not a sleep aid.

Questions Or Comments? (Questions or comments?)

1-855-328-5259

When Using This Product (When using this product)
  • avoid alcoholic drinks
  • marked drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
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.)

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) (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
Principal Display Panel (day/night Combination) (Principal Display Panel (Day/Night Combination))

MULTI-SYMPTOM COLD RELIEF

NEW FORMULA

VALUE PACK

DAYTIME FORMULA

SEVERE COLD RELIEF

MULTI-SYMPTOM COLD RELIEF

NEW FORMULA

THERAFLU

SEVERE COLD RELIEF + CHEST CONGESTION

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

SEVERE COLD RELIEF

HELPS YOU REST*

MULTI-SYMPTOM COLD RELIEF

NEW FORMULA

THERAFLU

SEVERE COLD RELIEF NIGHTTIME

Acetaminophen

Pain Reliever/Fever Reducer

Diphenhydramine HCl

Antihistamine/Cough Suppressant

HELPS YOU REST*

Powerful formula that relieves:

/ Cough

/ Sore throat pain

/ Head and body ache

/ Fever

/ Runny nose

/ Sneezing

8.3 FL OZ (245.5 mL) Berry Flavor

2-8.3 FL OZ (245.5 mL) BOTTLES TOTAL 16.6 FL OZ (491 mL)

USE ONLY AS DIRECTED

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


Raw Label Data

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