Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID f147d82e-4429-4c7b-bd2b-e21a09f21c92
Route
ORAL
Published
Effective Date 2024-04-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Dextromethorphan (20 mg) Diphenhydramine (650 mg)
Inactive Ingredients
Acesulfame Potassium Anhydrous Citric Acid Aspartame D&c Yellow No. 10 Fd&c Blue No. 1 Fd&c Red No. 40 Maltodextrin Silicon Dioxide Sodium Citrate, Unspecified Form Lecithin, Soybean Sucrose Tribasic Calcium Phosphate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-15

Description

Acetaminophen 500 mg Dextromethorphan HBr 20 mg

Purpose

Pain reliever/Fever reducer Cough suppressant


Medication Information

Purpose

Pain reliever/Fever reducer Cough suppressant

Description

Acetaminophen 500 mg Dextromethorphan HBr 20 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

Purposes

Pain reliever/Fever reducer

Cough suppressant

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

• take every 4 hours, while symptoms persist. Do not take more than 6 packets in 24 hours unless directed by a doctor.

Age

Dose

adults and children 12 years of age and over

one packet

children under 12 years of age

do not use



• dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.

• if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.

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

DO NOT TAKE THE THERAFLU SEVERE COLD RELIEF DAYTIME AND THERAFLU

SEVERE COLD RELIEF NIGHTTIME PRODUCTS AT THE SAME TIME.

DO NOT TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE.

KEEP CARTON FOR REFERENCE. DO NOT DISCARD.

DO NOT TAKE THE THERAFLU SEVERE COLD RELIEF DAYTIME AND THERAFLU

SEVERE COLD RELIEF 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 SEVERE COLD RELIEF NIGHTTIME PRODUCT

SOONER THAN 4 HOURS AFTER THE LAST DOSE OF SEVERE COLD RELIEF

DAYTIME PRODUCT UNLESS DIRECTED BY YOUR DOCTOR.

TAMPER EVIDENT INNER UNIT

DO NOT USE IF SEALED THERAFLU PACKET IS TORN OR BROKEN

1-855-328-5259

Distributed by: Haleon, Warren, NJ 07059

©2023 Haleon group of companies or its licensor.

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

Pat. Info www.productpats.com

207734

Other Information

• each packet contains: potassium 10 mg, sodium 20 mg

• phenylketonurics: contains phenylalanine 20 mg per packet

• store at controlled room temperature 20-25°C (68-77°F). Protect product from heat and moisture.

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.

Inactive Ingredients

acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, maltodextrin, natural and artificial flavors, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate

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.

Inactive Ingredients (nighttime)

acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, maltodextrin, natural and artificial flavors, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate

Active Ingredients (in Each Packet)

Acetaminophen 500 mg

Dextromethorphan HBr 20 mg

Active Ingredients (in Each Packet)

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have

• liver disease

• cough that occurs with too much phlegm (mucus)

• cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

Package/label Principal Display Panel

MULTI-SYMPTOM COLD RELIEF

NEW FORMULA

THERAFLU

SEVERE

COLD RELIEF

COMBO PACK

6 x DAYTIME

Acetaminophen Pain Reliever/Fever Reducer

Dextromethorphan HBr Cough Suppressant

6 x NIGHTTIME

Acetaminophen Pain reliever/Fever Reducer

Diphenhydramine HCl Antihistamine/Cough Suppressant

Hot liquid therapy that relieves:

/ Cough / Sore throat pain

/ Head and body ache / Fever

/ Runny nose (Nighttime only)

/ Sneezing (Nighttime only)

6 DAYTIME PACKETS

6 NIGHTTIME PACKETS

12 TOTAL PACKETS

Honey Lemon Flavor

USE 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

Purposes

Pain reliever/Fever reducer

Cough suppressant

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

• take every 4 hours, while symptoms persist. Do not take more than 6 packets in 24 hours unless directed by a doctor.

Age

Dose

adults and children 12 years of age and over

one packet

children under 12 years of age

do not use



• dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.

• if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.

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

DO NOT TAKE THE THERAFLU SEVERE COLD RELIEF DAYTIME AND THERAFLU

SEVERE COLD RELIEF NIGHTTIME PRODUCTS AT THE SAME TIME.

DO NOT TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE.

KEEP CARTON FOR REFERENCE. DO NOT DISCARD.

DO NOT TAKE THE THERAFLU SEVERE COLD RELIEF DAYTIME AND THERAFLU

SEVERE COLD RELIEF 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 SEVERE COLD RELIEF NIGHTTIME PRODUCT

SOONER THAN 4 HOURS AFTER THE LAST DOSE OF SEVERE COLD RELIEF

DAYTIME PRODUCT UNLESS DIRECTED BY YOUR DOCTOR.

TAMPER EVIDENT INNER UNIT

DO NOT USE IF SEALED THERAFLU PACKET IS TORN OR BROKEN

1-855-328-5259

Distributed by: Haleon, Warren, NJ 07059

©2023 Haleon group of companies or its licensor.

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

Pat. Info www.productpats.com

207734

Other Information (Other information)

• each packet contains: potassium 10 mg, sodium 20 mg

• phenylketonurics: contains phenylalanine 20 mg per packet

• store at controlled room temperature 20-25°C (68-77°F). Protect product from heat and moisture.

Warnings (daytime) (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.

Inactive Ingredients (Inactive ingredients)

acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, maltodextrin, natural and artificial flavors, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate

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.

Inactive Ingredients (nighttime) (Inactive Ingredients (Nighttime))

acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, maltodextrin, natural and artificial flavors, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate

Active Ingredients (in Each Packet) (Active Ingredients (in each packet))

Acetaminophen 500 mg

Dextromethorphan HBr 20 mg

Active Ingredients (in Each Packet) (Active ingredients (in each packet))

Acetaminophen 650 mg

Diphenhydramine HCl 25 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)

• cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

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

MULTI-SYMPTOM COLD RELIEF

NEW FORMULA

THERAFLU

SEVERE

COLD RELIEF

COMBO PACK

6 x DAYTIME

Acetaminophen Pain Reliever/Fever Reducer

Dextromethorphan HBr Cough Suppressant

6 x NIGHTTIME

Acetaminophen Pain reliever/Fever Reducer

Diphenhydramine HCl Antihistamine/Cough Suppressant

Hot liquid therapy that relieves:

/ Cough / Sore throat pain

/ Head and body ache / Fever

/ Runny nose (Nighttime only)

/ Sneezing (Nighttime only)

6 DAYTIME PACKETS

6 NIGHTTIME PACKETS

12 TOTAL PACKETS

Honey Lemon Flavor

USE 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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