Drug Facts
ebbb2f4b-ba84-40ad-96f6-60225119a33b
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 650 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg
Purpose
Pain reliever/Fever reducer Cough suppressant Nasal decongestant
Medication Information
Purpose
Pain reliever/Fever reducer Cough suppressant Nasal decongestant
Description
Acetaminophen 650 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg
Uses
-
•temporarily relieves these symptoms due to a cold:
-
ominor aches and pains
-
ominor sore throat pain
-
oheadache
-
onasal and sinus congestion
-
ocough due to minor throat and bronchial irritation
-
-
•temporarily reduces fever
Purposes
Pain reliever/Fever reducer
Cough suppressant
Nasal decongestant
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 5 packets in 24 hours unless directed by a doctor.
|
|
|
|
|
|
-
•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 14 mg per packet
-
•store at controlled room temperature 20 - 25°C (68 - 77°F). Protect product from heat and moisture.
Inactive Ingredients
acesulfame potassium, anhydrous citric acid, aspartame, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, 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.com
TAMPER EVIDENT INNER UNIT
DO NOT USE IF SEALED THERAFLU PACKET
IS TORN OR BROKEN
1-855-328-5259
Distributed by: GSK Consumer Healthcare
Warren, NJ 07059
©2022 GSK group of companies or its licensor.
Trademarks are owned by or licensed to the GSK group of companies.
PA_620000000201493
HOT LIQUID THERAPY
that relieves:
Nasal and sinus congestion
Cough
Sore throat pain
Headache
Fever
CARTON
RECYCLE
Questions Or Comments?
call 1-855-328-5259
Principal Display Panel
HALEON
NDC 0067-6800-02
MULTI-SYMPTOM COLD RELIEF
THERAFLU
SEVERE
COLD RELIEF
DAYTIME FORMULA
ACETAMINOPHEN
Paint Reliever/Fever Reducer
Dextromethorphan HBr
Cough Suppressant
PHENYLEPHRINE HCl
Nasal Decongestant
Hot liquid therapy
that relieves:
/ Nasal and sinus congestion
/ Cough
/ Sore throat pain
/ Headache
/ Fever
Berry Burst Flavor
6 PACKETS
When Using This Product
-
•do not exceed recommended dosage
Stop Use and Ask A Doctor If
-
•nervousness, dizziness, or sleeplessness occurs
-
•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 last 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 Packet)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Phenylephrine HCl 10 mg
Ask A Doctor Before Use If You Have
-
•liver disease
-
•heart disease
-
•high blood pressure
-
•thyroid disease
-
•diabetes
-
•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 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
-
onasal and sinus congestion
-
ocough due to minor throat and bronchial irritation
-
-
•temporarily reduces fever
Purposes
Pain reliever/Fever reducer
Cough suppressant
Nasal decongestant
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 5 packets in 24 hours unless directed by a doctor.
|
|
|
|
|
|
-
•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 (Other information)
-
•each packet contains: potassium 10 mg, sodium 20 mg
-
•phenylketonurics: contains phenylalanine 14 mg per packet
-
•store at controlled room temperature 20 - 25°C (68 - 77°F). Protect product from heat and moisture.
Inactive Ingredients (Inactive ingredients)
acesulfame potassium, anhydrous citric acid, aspartame, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, 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.com
TAMPER EVIDENT INNER UNIT
DO NOT USE IF SEALED THERAFLU PACKET
IS TORN OR BROKEN
1-855-328-5259
Distributed by: GSK Consumer Healthcare
Warren, NJ 07059
©2022 GSK group of companies or its licensor.
Trademarks are owned by or licensed to the GSK group of companies.
PA_620000000201493
HOT LIQUID THERAPY
that relieves:
Nasal and sinus congestion
Cough
Sore throat pain
Headache
Fever
CARTON
RECYCLE
Questions Or Comments? (Questions or Comments?)
call 1-855-328-5259
Principal Display Panel
HALEON
NDC 0067-6800-02
MULTI-SYMPTOM COLD RELIEF
THERAFLU
SEVERE
COLD RELIEF
DAYTIME FORMULA
ACETAMINOPHEN
Paint Reliever/Fever Reducer
Dextromethorphan HBr
Cough Suppressant
PHENYLEPHRINE HCl
Nasal Decongestant
Hot liquid therapy
that relieves:
/ Nasal and sinus congestion
/ Cough
/ Sore throat pain
/ Headache
/ Fever
Berry Burst Flavor
6 PACKETS
When Using This Product (When using this product)
-
•do not exceed recommended dosage
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
-
•nervousness, dizziness, or sleeplessness occurs
-
•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 last 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 Packet) (Active ingredients (in each packet))
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Phenylephrine HCl 10 mg
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
-
•liver disease
-
•heart disease
-
•high blood pressure
-
•thyroid disease
-
•diabetes
-
•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 (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: 2026-02-15T12:02:49.127259 · Updated: 2026-03-14T23:02:34.788055