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TherafluSevere Cold Relief

Dosage form
KIT
Labeler
Haleon US Holdings LLC
Label updated
2024-10-14
Retrieved
2026-09-07
Active ingredients
ACETAMINOPHEN · DEXTROMETHORPHAN HYDROBROMIDE · DIPHENHYDRAMINE HYDROCHLORIDE · GUAIFENESIN
View original label and images on DailyMed ↗
Active ingredients (in each 30 mL) (Daytime)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Purposes (Daytime)

Pain reliever/Fever reducer

Cough suppressant

Expectorant

Uses (Daytime)
  • •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
Warnings (Daytime)

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.

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.

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

Ask a doctor or pharmacist before use if you are

  • •taking the blood thinning drug warfarin

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.

Directions (Daytime)
  • 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

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

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? (Daytime)

1-855-328-5259

Active ingredients (in each 30 mL) (Nighttime)

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Purposes (Nighttime)

Pain reliever/Fever reducer

Antihistamine/Cough suppressant

Uses (Nighttime)
  • •temporarily relieves these symptoms due to a cold:
    • •minor aches and pains
    • •minor sore throat pain
    • •headache
    • •runny nose
    • •sneezing
    • •itchy nose or throat
    • •itchy, watery eyes due to hay fever
    • •cough due to minor throat and bronchial irritation
  • •temporarily reduces fever
Warnings (Nighttime)

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.

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.
  • •with any other product containing diphenhydramine, even one used on the skin
  • •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.

Ask a doctor before use if you have

  • •liver disease
  • •glaucoma
  • •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 or emphysema

Ask a doctor or pharmacist before use if you are

  • •taking sedatives or tranquilizers
  • •taking the blood thinning drug warfarin

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.

Directions (Nighttime)
  • 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

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

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? (Nighttime)

1-855-328-5259

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.

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

[Image in the official label — see DailyMed source]

DailyMed Set ID: b01cc9f5-53f2-40d8-acf1-6de180b3d0bf · Version 1
NDC: 0067-0107