Drug Facts

Drug Facts

SPL v3

SPL

SPL Set ID a1405038-80f2-45e5-bd8c-8c6b0ee348be

Route

ORAL

Published

Effective Date 2025-05-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Acetaminophen (1000 mg) Dextromethorphan (30 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 Soybean Lecithin Sucrose Tribasic Calcium Phosphate

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-06-15

Description

Acetaminophen 1000 mg Dextromethorphan HBr 30 mg

Purpose

Pain reliever/Fever reducer Cough suppressant

Medication Information

Purpose

Pain reliever/Fever reducer Cough suppressant

Description

Acetaminophen 1000 mg Dextromethorphan HBr 30 mg

Uses

temporarily relieves these symptoms due to a common cold or flu:
- headache
- minor aches and pains
- cough due to minor throat and bronchial irritation
- minor sore throat pain
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 6 hours, while symptoms persist. Do not take more than 3 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

each packet contains:potassium 10 mg, sodium 20 mg
phenylketonurics:contains phenylalanine 19.6 mg per packet
store at a controlled room temperature at 20 – 25°C (68 – 77°F)

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

Additional Information

READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD.

HOT LIQUID THERAPYthat relieves:

Fever

Body ache

Headache

Sore throat pain

Cough

*Maximum Strength per 6 hour dose

PARENTS:Learn about teen medicine abuse

www.StopMedicineAbuse.org

TAMPER EVIDENT INNER UNIT DO NOT USE IF SEALED THERAFLU PACKET IS TORN OR BROKEN

1-855-297-3031

Distributed by: Haleon, Warren, NJ 07059

Trademarks are owned by or licensed to the

Haleon group of companies.

62000000217491

Questions Or Comments?

1-855-297-3031

Principal Display Panel

MULTI-SYMPTOM FLU RELIEF

HALEON

THERAFLU

FLU RELIEF

MAX STRENGTH*

Acetaminophen

Pain Reliever/Fever Reducer

Dextromethorphan HBr

Cough Suppressant

DAYTIME FORMULA

Hot liquid therapy that relieves:

/ Fever

/ Body ache

/ Headache

/ Sore throat pain

/ Cough

Honey Lemon Flavor

6 PACKETS

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.

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 Packet)

Acetaminophen 1000 mg

Dextromethorphan HBr 30 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

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 common cold or flu:
- headache
- minor aches and pains
- cough due to minor throat and bronchial irritation
- minor sore throat pain
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 6 hours, while symptoms persist. Do not take more than 3 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 (Other information)

each packet contains:potassium 10 mg, sodium 20 mg
phenylketonurics:contains phenylalanine 19.6 mg per packet
store at a controlled room temperature at 20 – 25°C (68 – 77°F)

Inactive Ingredients (Inactive ingredients)

Additional Information

READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD.

HOT LIQUID THERAPYthat relieves:

Fever

Body ache

Headache

Sore throat pain

Cough

*Maximum Strength per 6 hour dose

PARENTS:Learn about teen medicine abuse

www.StopMedicineAbuse.org

TAMPER EVIDENT INNER UNIT DO NOT USE IF SEALED THERAFLU PACKET IS TORN OR BROKEN

1-855-297-3031

Distributed by: Haleon, Warren, NJ 07059

Trademarks are owned by or licensed to the

Haleon group of companies.

62000000217491

Questions Or Comments? (Questions or comments?)

1-855-297-3031

Principal Display Panel

MULTI-SYMPTOM FLU RELIEF

HALEON

THERAFLU

FLU RELIEF

MAX STRENGTH*

Acetaminophen

Pain Reliever/Fever Reducer

Dextromethorphan HBr

Cough Suppressant

DAYTIME FORMULA

Hot liquid therapy that relieves:

/ Fever

/ Body ache

/ Headache

/ Sore throat pain

/ Cough

Honey Lemon Flavor

6 PACKETS

Stop Use and Ask A Doctor If (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.

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 Packet) (Active ingredients (in each packet))

Acetaminophen 1000 mg

Dextromethorphan HBr 30 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

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

[{"name": "ACESULFAME POTASSIUM", "unii": "23OV73Q5G9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ASPARTAME", "unii": "Z0H242BBR1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C YELLOW NO. 10", "unii": "35SW5USQ3G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE, UNSPECIFIED FORM", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SOYBEAN LECITHIN", "unii": "1DI56QDM62", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIBASIC CALCIUM PHOSPHATE", "unii": "91D9GV0Z28", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "1000", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to a common cold or flu: headache minor aches and pains cough due to minor throat and bronchial irritation minor sore throat pain 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 6 hours, while symptoms persist. Do not take more than 3 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": "each packet contains: potassium 10 mg, sodium 20 mg phenylketonurics: contains phenylalanine 19.6 mg per packet store at a controlled room temperature at 20 – 25°C (68 – 77°F)", "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", "Additional Information": "READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD. HOT LIQUID THERAPY that relieves: Fever Body ache Headache Sore throat pain Cough *Maximum Strength per 6 hour dose PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org TAMPER EVIDENT INNER UNIT DO NOT USE IF SEALED THERAFLU PACKET IS TORN OR BROKEN 1-855-297-3031 Distributed by: Haleon, Warren, NJ 07059 Trademarks are owned by or licensed to the Haleon group of companies. ©2025 Haleon group of companies or its licensor. 62000000217491", "Questions or comments?": "1-855-297-3031", "Principal Display Panel": "MULTI-SYMPTOM FLU RELIEF HALEON THERAFLU FLU RELIEF MAX STRENGTH* Acetaminophen Pain Reliever/Fever Reducer Dextromethorphan HBr Cough Suppressant DAYTIME FORMULA Hot liquid therapy that relieves: / Fever / Body ache / Headache / Sore throat pain / Cough Honey Lemon Flavor 6 PACKETS", "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.", "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 packet)": "Acetaminophen 1000 mg Dextromethorphan HBr 30 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", "Ask a doctor or pharmacist before use if you are": "taking the blood thinning drug warfarin"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:08.593307 · Updated: 2026-03-14T23:08:46.104923