drug facts

drug facts
SPL v4
SPL
SPL Set ID 8e22f6bc-33ce-4bb0-99be-7947aa21f60e
Route
oral
Published
Effective Date 2024-03-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (325 mg) dextromethorphan (10 mg) guaifenesin (200 mg) phenylephrine (5 mg)
Inactive Ingredients
benzoic acid carminic acid croscarmellose sodium crospovidone, unspecified alcohol ferric oxide yellow hypromellose, unspecified maltodextrin microcrystalline cellulose polyethylene glycol, unspecified polysorbate 60 polysorbate 80 povidone, unspecified starch, corn propylene glycol silicon dioxide stearic acid sucralose titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: IL5 Shape: oval Color: red Size: 19 mm Score: 1
Marketing Status
otc monograph drug active Since 2017-07-17
Purpose

Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Medication Information

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.

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
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Purpose

Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

Directions
  • do not use more than directed
  • adults and children 12 years of age and over: take 2 caplets every 4 hours, while symptoms persist. Do not take more than 10 caplets in 24 hours unless directed by a doctor.
  • children under 12 years of age: do not use
Other Information
  • each caplet contains: sodium 5 mg
  • store at controlled room temperature 20-25°C (68-77°F)
Inactive Ingredients

benzoic acid, carmine, croscarmellose sodium, crospovidone, ethanol, ferric oxide yellow, flavors, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 60, polysorbate 80, povidone, pregelatinized starch, propylene glycol, silicon dioxide, stearic acid, sucralose, titanium dioxide

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

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.
Questions Or Comments?

call 1-855-328-5259

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.

Active Ingredients (in Each Caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 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, chromic bronchitis or emphysema
Package/label Principal Display Panel

NDC 0067-8145-01

Theraflu ® Expressmax ™

SEVERE COLD AND FLU

NEW!

WARMING RELIEF FORMULA

ACETAMINOPHEN- PAIN RELIEVER/ FEVER REDUCER

DEXTROMETHORPHAN HBr- COUGH SUPPRESSANT

GUAIFENESIN- EXPECTORANT

PHENYLEPHRINE HCl- NASAL DECONGESTANT

  • BODY ACHE
  • FEVER
  • CHEST CONGESTION
  • NASAL CONGESTION
  • HEADACHE
  • COUGH
  • SORE THROAT PAIN
  • COATED CAPLETS
  • PARENTS:
  • Learn about teen medicine abuse
  • www.StopMedicineAbuse.org
  • *Maximum Strength per 4 hour dose.
  • TAMPER EVIDENT FEATURE:
  • THERAFLU ®EXPRESSMAX ™CAPLETS ARE SEALED IN BLISTER PACKETS. USE ONLY IF THE INDIVIDUAL SEAL IS UNBROKEN.
  • Read all warnings and directions on carton before use. Keep carton for reference. Do not discard.
  • Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
  • Trademarks are owned or licensed to the GSK group of companies.
  • © 2016 GSK group of companies or its licensor. All rights reserved.
Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin

Structured Label Content

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.

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
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Directions
  • do not use more than directed
  • adults and children 12 years of age and over: take 2 caplets every 4 hours, while symptoms persist. Do not take more than 10 caplets in 24 hours unless directed by a doctor.
  • children under 12 years of age: do not use
Other Information (Other information)
  • each caplet contains: sodium 5 mg
  • store at controlled room temperature 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

benzoic acid, carmine, croscarmellose sodium, crospovidone, ethanol, ferric oxide yellow, flavors, hypromellose, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 60, polysorbate 80, povidone, pregelatinized starch, propylene glycol, silicon dioxide, stearic acid, sucralose, titanium dioxide

Purposes

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

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.
Questions Or Comments? (Questions or Comments?)

call 1-855-328-5259

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.)

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 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 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, chromic bronchitis or emphysema
Package/label Principal Display Panel (Package/Label Principal Display Panel)

NDC 0067-8145-01

Theraflu ® Expressmax ™

SEVERE COLD AND FLU

NEW!

WARMING RELIEF FORMULA

ACETAMINOPHEN- PAIN RELIEVER/ FEVER REDUCER

DEXTROMETHORPHAN HBr- COUGH SUPPRESSANT

GUAIFENESIN- EXPECTORANT

PHENYLEPHRINE HCl- NASAL DECONGESTANT

  • BODY ACHE
  • FEVER
  • CHEST CONGESTION
  • NASAL CONGESTION
  • HEADACHE
  • COUGH
  • SORE THROAT PAIN
  • COATED CAPLETS
  • PARENTS:
  • Learn about teen medicine abuse
  • www.StopMedicineAbuse.org
  • *Maximum Strength per 4 hour dose.
  • TAMPER EVIDENT FEATURE:
  • THERAFLU ®EXPRESSMAX ™CAPLETS ARE SEALED IN BLISTER PACKETS. USE ONLY IF THE INDIVIDUAL SEAL IS UNBROKEN.
  • Read all warnings and directions on carton before use. Keep carton for reference. Do not discard.
  • Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
  • Trademarks are owned or licensed to the GSK group of companies.
  • © 2016 GSK group of companies or its licensor. All rights reserved.
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

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:50.894644 · Updated: 2026-03-14T23:02:37.591705