Drug Facts

Drug Facts

SPL v8

SPL

SPL Set ID c0689223-5c90-4dbc-bbfa-f94e267504c3

Route

ORAL

Published

Effective Date 2024-01-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Acetaminophen (650 mg) Dextromethorphan (20 mg) Phenylephrine (10 mg)

Inactive Ingredients

Acesulfame Potassium Anhydrous Citric Acid Aspartame Fd&c Blue No. 1 Fd&c Red No. 40 Maltodextrin Silicon Dioxide Sodium Citrate, Unspecified Form Sucrose Tribasic Calcium Phosphate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2012-09-24

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:
- minor aches and pains
- minor sore throat pain
- headache
- nasal and sinus congestion
- cough 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.

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 14 mg per packet
store at controlled room temperature 20 ^o-25 ^oC (68 ^o-77 ^oF). Protect product from heat and moisture.

Principal Display

NDC 0067-7917-06

THERAFLU _®

DAYTIME

SEVERE COLD & COUGH

ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUER

DEXTROMETHORPHAN HBr – COUGH SUPPRESSANT

PHENYLEPHRINE HCl – NASAL DECONGESTANT

NASAL CONGESTION
SORE THROAT PAIN
COUGH
HEADACHE
BODY ACHE
FEVER

Berry

Infused with Menthol & Green Tea Flavors

6 PACKETS

Theraflu ^®provides powerful relief from your severe cold and flu symptoms.

www.theraflu.com

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 THERAFLU ^®PACKET IS TORN OR BROKEN

1-800-452-0051

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

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

62000000010752

Inactive Ingredients

acesulfame potassium, anhydrous citric acid, aspartame, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate

Questions Or Comments?

call 1-800-452-0051

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 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
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

Active Ingredient (in Each Packet)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 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:
- minor aches and pains
- minor sore throat pain
- headache
- nasal and sinus congestion
- cough 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.

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 14 mg per packet
store at controlled room temperature 20 ^o-25 ^oC (68 ^o-77 ^oF). Protect product from heat and moisture.

Principal Display

NDC 0067-7917-06

THERAFLU _®

DAYTIME

SEVERE COLD & COUGH

ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUER

DEXTROMETHORPHAN HBr – COUGH SUPPRESSANT

PHENYLEPHRINE HCl – NASAL DECONGESTANT

NASAL CONGESTION
SORE THROAT PAIN
COUGH
HEADACHE
BODY ACHE
FEVER

Berry

Infused with Menthol & Green Tea Flavors

6 PACKETS

Theraflu ^®provides powerful relief from your severe cold and flu symptoms.

www.theraflu.com

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 THERAFLU ^®PACKET IS TORN OR BROKEN

1-800-452-0051

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

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

62000000010752

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, sucrose, tribasic calcium phosphate

Questions Or Comments? (Questions or comments?)

call 1-800-452-0051

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 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.)

Ask Doctor Before Use If You Have (Ask 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

Active Ingredient (in Each Packet) (Active ingredient (in each packet))

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 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

[{"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": "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": "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": "650", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion cough 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. 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 14 mg per packet store at controlled room temperature 20 o -25 o C (68 o -77 o F). Protect product from heat and moisture.", "Principal Display": "NDC 0067-7917-06 THERAFLU ® DAYTIME SEVERE COLD & COUGH ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUER DEXTROMETHORPHAN HBr – COUGH SUPPRESSANT PHENYLEPHRINE HCl – NASAL DECONGESTANT NASAL CONGESTION SORE THROAT PAIN COUGH HEADACHE BODY ACHE FEVER Berry Infused with Menthol & Green Tea Flavors 6 PACKETS Theraflu ® provides powerful relief from your severe cold and flu symptoms. www.theraflu.com 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 THERAFLU ® PACKET IS TORN OR BROKEN 1-800-452-0051 Distributed by: GSK Consumer Healthcare Warren, NJ 07059 ©2017 GSK group of companies or its licensor. All rights reserved. Trademarks are owned by or licensed to the GSK group of companies. 62000000010752", "Inactive ingredients": "acesulfame potassium, anhydrous citric acid, aspartame, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate", "Questions or comments?": "call 1-800-452-0051", "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 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 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", "Active ingredient (in each packet)": "Acetaminophen 650 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg", "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: 2026-02-15T12:02:45.139847 · Updated: 2026-03-14T23:02:27.804765