Theraflu Daytime Severe Cold and Cough ACETAMINOPHEN DEXTROMETHORPHAN PHENYLEPHRINE 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
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each packet) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg
Inactive Ingredients
Inactive ingredients acesulfame potassium anhydrous citric acid aspartame FD&C blue no. 1 FD&C red no. 40 flavors maltodextrin silicon dioxide sodium citrate sucrose tribasic calcium phosphate
Strengths
650 mg 20 mg 10 mg
Quantities
6 pack
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

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
362O9ITL9D 9D2RTI9KYH 04JA59TNSJ
Packaging

Principal Display NDC 0067-7917-06 THERAFLU ® DAYTIME SEVERE COLD & COUGH ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUER DEXTROMETHORPHAN HBr – COUGH SUPPRESSANT PHENYLEPHRINE HCl – NASAL DECONGESTANT NASAL CONGESTION SORE THROAT PAIN COUGH HEADACHE BODY ACHE FEVER Berry Infused with Menthol & Green Tea Flavors 6 PACKETS Theraflu ® provides powerful relief from your severe cold and flu symptoms. www.theraflu.com 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 TAMPER EVIDENT INNER UNIT DO NOT USE IF SEALED THERAFLU ® PACKET IS TORN OR BROKEN 1-800-452-0051 Distributed by: GSK Consumer Healthcare Warren, NJ 07059 ©2017 GSK group of companies or its licensor. All rights reserved. Trademarks are owned by or licensed to the GSK group of companies. 62000000010752 62000000010752_Theraflu Daytime SCC packets_6 ct.JPG

Package Descriptions
  • Principal Display NDC 0067-7917-06 THERAFLU ® DAYTIME SEVERE COLD & COUGH ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUER DEXTROMETHORPHAN HBr – COUGH SUPPRESSANT PHENYLEPHRINE HCl – NASAL DECONGESTANT NASAL CONGESTION SORE THROAT PAIN COUGH HEADACHE BODY ACHE FEVER Berry Infused with Menthol & Green Tea Flavors 6 PACKETS Theraflu ® provides powerful relief from your severe cold and flu symptoms. www.theraflu.com 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 TAMPER EVIDENT INNER UNIT DO NOT USE IF SEALED THERAFLU ® PACKET IS TORN OR BROKEN 1-800-452-0051 Distributed by: GSK Consumer Healthcare Warren, NJ 07059 ©2017 GSK group of companies or its licensor. All rights reserved. Trademarks are owned by or licensed to the GSK group of companies. 62000000010752 62000000010752_Theraflu Daytime SCC packets_6 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 take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor. Age Dose adults and children 12 years of age and over one packet children under 12 years of age do not use dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.

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 a 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 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

Purposes 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 a 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.

Storage & Handling

Other information each packet contains: potassium 10 mg, sodium 20 mg phenylketonurics: contains phenylalanine 14 mg per packet store at controlled room temperature 20 o -25 o C (68 o -77 o F). Protect product from heat and moisture.

Questions

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


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