Theraflu ExpressMax Severe Cold and Flu Syrup ACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN 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 helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg
Inactive Ingredients
Inactive ingredients acesulfame potassium anhydrous citric acid edetate disodium FD&C blue no. 1 FD&C red no. 40 flavors glycerin maltitol solution propylene glycol purified water sodium benzoate sodium citrate
Strengths
30 ml 650 mg 20 mg 400 mg 10 mg
Quantities
5 ml
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 Helps Loosen Phlegm Mucus And Thin Bronchial Secretions To Rid The Bronchial Passageways Of Bothersome Mucus And Make Coughs More Productive
Pill Appearance
Color: red

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
362O9ITL9D 9D2RTI9KYH 495W7451VQ 04JA59TNSJ
Packaging

Package/Label Principal Display Panel NDC 0067-8132-08 Theraflu ® Expressmax ™ SEVERE COLD AND FLU 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 ALCOHOL FREE BERRY FLAVOR 8.3 FL OZ (245.5 mL) PARENTS : Learn about teen medicine abuse www.StopMedicineAbuse.org *Maximum Strength per 4 hour dose. 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. 12265_Theraflu expressmax severe cold and flu syrup.jpg

Package Descriptions
  • Package/Label Principal Display Panel NDC 0067-8132-08 Theraflu ® Expressmax ™ SEVERE COLD AND FLU 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 ALCOHOL FREE BERRY FLAVOR 8.3 FL OZ (245.5 mL) PARENTS : Learn about teen medicine abuse www.StopMedicineAbuse.org *Maximum Strength per 4 hour dose. 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. 12265_Theraflu expressmax severe cold and flu syrup.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 helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

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

Dosage & Administration

Directions do not use more than directed measure the dose correctly using the enclosed dosing cup take every 4 hours in dosing cup provided, while symptoms persist do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor Age Dose adults and children 12 years of age and over 30 mL children under 12 years of age do not use

Warnings & Precautions
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. 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, chronic bronchitis 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

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.

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 1-855-328-5259


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