Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 62f7fcb9-e31a-4634-b1c2-44a9567e3a61
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) Diphenhydramine (12.5 mg) Phenylephrine (5 mg)
Inactive Ingredients
Benzoic Acid Croscarmellose Sodium Alcohol Fd&c Blue No. 2 Aluminum Oxide Ferrosoferric Oxide Hypromellose, Unspecified Magnesium Stearate 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: 1143N Shape: oval Color: blue Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-07-05

Description

Acetaminophen 325 mg Diphenhydramine HCl 12.5 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer Antihistamine/cough suppressant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Antihistamine/cough suppressant

Nasal decongestant

Description

Acetaminophen 325 mg Diphenhydramine HCl 12.5 mg Phenylephrine HCl 5 mg

Uses
  • temporarily relieves these symptoms due to a cold:
    • minor aches and pains
    • minor sore throat pain
    • headache
    • nasal and sinus congestion
    • runny nose
    • sneezing
    • itchy nose or throat
    • itchy, watery eyes due to hay fever
    • cough due to minor throat and bronchial irritation
  • temporarily reduces fever
Warnings

Liver warning:This product contains acetaminophen. Severe lever 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 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
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.
  • with any other product containing diphenhydramine, even one used on the skin
  • 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.
Active Ingredient

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg

Other Information
  • store at controlled room temperature 20°-25°C (68°-77°F)
Inactive Ingredients

benzoic acid, croscarmellose sodium, ethanol, FD&C blue no.2 aluminum lake, ferrosoferric oxide, flavors, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 60, polysorbate 80, povidone, pregelatinized starch, propylene glycol, silicone dioxide, stearic acid, sucralose, titanium dioxide

Questions Or Comments?

call 1-800-452-0051

Principal Display Panel

NDC 0067-8137-20

Theraflu ®Express Max ®

NIGHTTIME

SEVERE COLD & COUGH

WARMING RELIEF™ FORMULA

ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER

DIPHENHYDRAMINE HCl – ANTIHISTAMINE/COUGH SUPPRESSANT

PEHNYLEPHRINE HCl – NASAL DECONGESTANT

  • NASAL CONGESTION • SORE THROAT • FEVER • BODY ACHE
  • RUNNY NOSE • HEADACHE • COUGH • SNEEZING

20 COATED CAPLETS

*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 by or licensed to the GSK group of companies.

©2016 GSK group of companies or its licensor. All rights reserved.

62000000010602

When Using This Product
  • do not exceed recommended dosage
  • 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
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 A Doctor Before Use If You Have
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • 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 sedatives or tranquilizers
  • 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
    • runny nose
    • sneezing
    • itchy nose or throat
    • itchy, watery eyes due to hay fever
    • cough due to minor throat and bronchial irritation
  • temporarily reduces fever
Purpose

Pain reliever/fever reducer

Antihistamine/cough suppressant

Nasal decongestant

Warnings

Liver warning:This product contains acetaminophen. Severe lever 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 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
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.
  • with any other product containing diphenhydramine, even one used on the skin
  • 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.
Active Ingredient (Active ingredient)

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg

Other Information (Other information)
  • store at controlled room temperature 20°-25°C (68°-77°F)
Inactive Ingredients (Inactive ingredients)

benzoic acid, croscarmellose sodium, ethanol, FD&C blue no.2 aluminum lake, ferrosoferric oxide, flavors, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 60, polysorbate 80, povidone, pregelatinized starch, propylene glycol, silicone dioxide, stearic acid, sucralose, titanium dioxide

Questions Or Comments? (Questions or comments?)

call 1-800-452-0051

Principal Display Panel

NDC 0067-8137-20

Theraflu ®Express Max ®

NIGHTTIME

SEVERE COLD & COUGH

WARMING RELIEF™ FORMULA

ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER

DIPHENHYDRAMINE HCl – ANTIHISTAMINE/COUGH SUPPRESSANT

PEHNYLEPHRINE HCl – NASAL DECONGESTANT

  • NASAL CONGESTION • SORE THROAT • FEVER • BODY ACHE
  • RUNNY NOSE • HEADACHE • COUGH • SNEEZING

20 COATED CAPLETS

*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 by or licensed to the GSK group of companies.

©2016 GSK group of companies or its licensor. All rights reserved.

62000000010602

When Using This Product (When using this product)
  • do not exceed recommended dosage
  • 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
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.

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
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • 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 sedatives or tranquilizers
  • taking the blood thinning drug warfarin

Advanced Ingredient Data


Raw Label Data

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