Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 68d3e88a-d1be-410b-92a1-863903b3aa61
Route
ORAL
Published
Effective Date 2022-06-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Dextromethorphan (15 mg) Chlorpheniramine (2 mg)
Inactive Ingredients
Crospovidone, Unspecified D&c Yellow No. 10 Aluminum Lake Fd&c Red No. 40 Fd&c Yellow No. 6 Aluminum Oxide Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Povidone, Unspecified Starch, Corn Silicon Dioxide Sodium Starch Glycolate Type A Potato Stearic Acid Talc Titanium Dioxide Fd&c Blue No. 2

Identifiers & Packaging

Pill Appearance
Imprint: NT;1 Shape: oval Color: red Color: blue Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-06-27
Description

Acetaminophen 500 mg Dextromethorphan HBr 15 mg

Purpose

Pain reliever/Fever reducer Cough suppressant

Medication Information

Purpose

Pain reliever/Fever reducer Cough suppressant

Description

Acetaminophen 500 mg Dextromethorphan HBr 15 mg

Uses
  • temporarily relieves these symptoms due to a common cold:
    • 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
  • Adults and children 12 years of age and over: take 2 caplets every 6 hours, while symptoms persist
  • do not take more than 6 caplets in 24 hours unless directed by a doctor
  • children under 12 years of age: do not use
  • Age
  • Dose
  • adults and children 12 years of age and over
  • 2 caplets every 6 hours
  • children under 12 years of age
  • 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
  • store at controlled room temperature 20-25°C (68-77°F)
Inactive Ingredients

crospovidone, D&C yellow no. 10 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl

alcohol, povidone, pregelatinized starch, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions Or Comments?

call 1-855-328-5259

Principal Display Panel

NDC 0067-8161-01

THERAFLU

FLU RELIEF

MAX STRENGTH*

MULTI-SYMPTOM FLU RELIEF

Powerful fever fightingformula that relieves:

/ Body ache / Headache

/ Sore throat pain / cough

/ Runny nose (Nighttime only)

DAYTIME

Acetaminophen

Pain Reliever / Fever Reducer

Dextromethorphan HBr

Cough Suppressant

NIGHTTIME

Acetaminophen

Pain Reliever / Fever Reducer

Chlorpheniramine Maleate

Antihistamine

Dextromethorphan HBr

Cough Suppressant

20 DAYTIME CAPLETS

20 NIGHTTIME CAPLETS

40 TOTAL CAPLETS

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
Other Safety Information

DO NOT TAKE THE DAYTIME AND NIGHTTIME PRODUCTS AT THE SAME TIME.

DO NOT TAKE MORE THAN 3 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.

PARENTS:Learn about teen medicine abuse

www.StopMedicineAbuse.org

*Maximum Strength per 6 hour dose.

TAMPER-EVIDENT FEATURE: THERAFLU FLU RELIEF MAX STRENGTH CAPLETS ARE SEALED IN BLISTER PACKETS. USE ONLY IF THE INDIVIDUAL SEAL IS UNBROKEN.

READ ALLWARNINGS AND DIRECTIONS ON CARTON BEFORE USE.

KEEP CARTON FOR REFERENCE. DO NOT DISCARD.

DO NOT TAKE A DOSE OF THE NIGHTTIME PRODUCT SOONER THAN 6 HOURS AFTER THE LAST DOSE OF THE DAYTIME PRODUCT UNLESS DIRECTED BY YOUR DOCTOR.

DO NOT TAKE THE DAYTIME AND NIGHTTIME PRODUCTS AT THE SAME TIME.

DO NOT TAKE MORE THAN 3 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.

Distributed by: GSK Consumer Healthcare

Warren, NJ 07059

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

©2022 GSK group of companies or its licensor.

B-0630-770771-10 REV A

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 Caplet)

Acetaminophen 500 mg

Dextromethorphan HBr 15 mg

Ask A Doctor Before Use If You Have
  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • 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:
    • 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
  • Adults and children 12 years of age and over: take 2 caplets every 6 hours, while symptoms persist
  • do not take more than 6 caplets in 24 hours unless directed by a doctor
  • children under 12 years of age: do not use
  • Age
  • Dose
  • adults and children 12 years of age and over
  • 2 caplets every 6 hours
  • children under 12 years of age
  • do not use
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)
  • store at controlled room temperature 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

crospovidone, D&C yellow no. 10 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl

alcohol, povidone, pregelatinized starch, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

call 1-855-328-5259

Principal Display Panel

NDC 0067-8161-01

THERAFLU

FLU RELIEF

MAX STRENGTH*

MULTI-SYMPTOM FLU RELIEF

Powerful fever fightingformula that relieves:

/ Body ache / Headache

/ Sore throat pain / cough

/ Runny nose (Nighttime only)

DAYTIME

Acetaminophen

Pain Reliever / Fever Reducer

Dextromethorphan HBr

Cough Suppressant

NIGHTTIME

Acetaminophen

Pain Reliever / Fever Reducer

Chlorpheniramine Maleate

Antihistamine

Dextromethorphan HBr

Cough Suppressant

20 DAYTIME CAPLETS

20 NIGHTTIME CAPLETS

40 TOTAL CAPLETS

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
Other Safety Information

DO NOT TAKE THE DAYTIME AND NIGHTTIME PRODUCTS AT THE SAME TIME.

DO NOT TAKE MORE THAN 3 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.

PARENTS:Learn about teen medicine abuse

www.StopMedicineAbuse.org

*Maximum Strength per 6 hour dose.

TAMPER-EVIDENT FEATURE: THERAFLU FLU RELIEF MAX STRENGTH CAPLETS ARE SEALED IN BLISTER PACKETS. USE ONLY IF THE INDIVIDUAL SEAL IS UNBROKEN.

READ ALLWARNINGS AND DIRECTIONS ON CARTON BEFORE USE.

KEEP CARTON FOR REFERENCE. DO NOT DISCARD.

DO NOT TAKE A DOSE OF THE NIGHTTIME PRODUCT SOONER THAN 6 HOURS AFTER THE LAST DOSE OF THE DAYTIME PRODUCT UNLESS DIRECTED BY YOUR DOCTOR.

DO NOT TAKE THE DAYTIME AND NIGHTTIME PRODUCTS AT THE SAME TIME.

DO NOT TAKE MORE THAN 3 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.

Distributed by: GSK Consumer Healthcare

Warren, NJ 07059

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

©2022 GSK group of companies or its licensor.

B-0630-770771-10 REV A

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.)

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 Caplet) (Active ingredients (in each caplet))

Acetaminophen 500 mg

Dextromethorphan HBr 15 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • 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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:50.988390 · Updated: 2026-03-14T23:02:37.591705