Drug Facts
2b962d87-6ff5-4c0f-8504-e5b61c940612
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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:
-
ominor aches and pains
-
ominor sore throat pain
-
oheadache
-
ocough 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 a 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 20 mg per packet
-
•store at controlled room temperature 20o-25oC (68o - 77oF). Protect product from heat and moisture.
Principal Display
NEW FORMULA
HALEON
THERAFLU
SEVERE COLD RELIEF
Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
DAYTIME FORMULA
Hot liquid therapy that relieves:
-
/ Cough
/ Sore throat pain
/ Head and body ache
/ Fever
Honey Lemon Flavor
6 PACKETS
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.
PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
TAMPER EVIDENT INNER UNIT
DO NOT USE IF SEALED THERAFLUPACKET 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
62000000207707
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, cough or nasal congestion 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.
Ask 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
Active Ingredients (in Each Packet)
Acetaminophen 500 mg
Dextromethorphan HBr 20 mg
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:
-
ominor aches and pains
-
ominor sore throat pain
-
oheadache
-
ocough 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 a 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 20 mg per packet
-
•store at controlled room temperature 20o-25oC (68o - 77oF). Protect product from heat and moisture.
Principal Display
NEW FORMULA
HALEON
THERAFLU
SEVERE COLD RELIEF
Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
DAYTIME FORMULA
Hot liquid therapy that relieves:
-
/ Cough
/ Sore throat pain
/ Head and body ache
/ Fever
Honey Lemon Flavor
6 PACKETS
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
Additional Information (Additional information)
READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE.
KEEP CARTON FOR REFERENCE. DO NOT DISCARD.
PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
TAMPER EVIDENT INNER UNIT
DO NOT USE IF SEALED THERAFLUPACKET 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
62000000207707
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, cough or nasal congestion 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.
Ask Doctor Before Use If You Have (Ask 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
Active Ingredients (in Each Packet) (Active ingredients (in each packet))
Acetaminophen 500 mg
Dextromethorphan HBr 20 mg
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
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:06:03.383456 · Updated: 2026-03-14T23:08:35.242045