Theraflu ExpressMax Daytime Severe Cold and Cough ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL HALEON US HOLDINGS LLC FDA Approved 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
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Substance Acetaminophen
Route
ORAL
Applications
M012

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg
Inactive Ingredients
Inactive ingredients benzoic acid carmine croscarmellose sodium ethanol ferric oxide yellow flavors hypromellose magnesium stearate maltodextrin microcrystalline cellulose polyethylene glycol polysorbate 60 polysorbate 80 povidone pregelatinized starch propylene glycol silicon dioxide stearic acid sucralose titanium dioxide
Strengths
325 mg 10 mg 5 mg
Quantities
62000000010595 count
Treats Conditions
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
Pill Appearance
Shape: oval Color: red Imprint: 1143D

Identifiers & Packaging

Container Type BOX
UNII
362O9ITL9D 9D2RTI9KYH 04JA59TNSJ
Packaging

Principal Display Panel NDC 0067-8136-20 Theraflu ® ExpressMax ® DAYTIME SEVERE COLD & COUGH WARMING RELIEF™ FORMULA ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER DEXTROMETHORPHAN HBr – COUGH SUPPRESSANT PEHNYLEPHRINE HCl – NASAL DECONGESTANT NASAL CONGESTION • SORE THROAT HEADACHE • BODY ACHE • COUGH • FEVER 20 COATED CAPLETS 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 *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. 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. www.theraflu.com 62000000010595 62000000010595_Theraflu Expressmax SCC caplets_20 ct.JPG

Package Descriptions
  • Principal Display Panel NDC 0067-8136-20 Theraflu ® ExpressMax ® DAYTIME SEVERE COLD & COUGH WARMING RELIEF™ FORMULA ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER DEXTROMETHORPHAN HBr – COUGH SUPPRESSANT PEHNYLEPHRINE HCl – NASAL DECONGESTANT NASAL CONGESTION • SORE THROAT HEADACHE • BODY ACHE • COUGH • FEVER 20 COATED CAPLETS 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 *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. 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. www.theraflu.com 62000000010595 62000000010595_Theraflu Expressmax SCC caplets_20 ct.JPG

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & Precautions
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. 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. 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 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.
Purpose

Purpose Pain reliever/fever reducer Cough suppressant 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.

When Using

When using this product do not exceed recommended dosage

Stop Use & Ask a Doctor

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.

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.

Questions

Questions or Comments? call 1-800-452-0051


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