Duraflu ACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PSEUDOEPHEDRINE HCL POLY PHARMACEUTICALS, INC. FDA Approved Temporarily relieves minor aches and pains fever headache cough due to minor throat and bronchial irritation helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes nasal congestion due to the common cold
FunFoxMeds box
Substance Acetaminophen
Route
ORAL
Applications
M012

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredients Acetaminophen 325 mg Dextromethorphan HBr 20 mg Guaifenesin 200 mg Pseudoephedrine HCl 60 mg
Inactive Ingredients
Inactive ingredients magnesium stearate microcrystalline cellulose stearic acid
Strengths
325 mg 20 mg 200 mg 60 mg
Quantities
100 tablets
Treats Conditions
Temporarily Relieves Minor Aches And Pains Fever Headache Cough Due To Minor Throat And Bronchial Irritation Helps Loosen Phlegm Mucus And Thin Bronchial Secretions To Drain Bronchial Tubes Nasal Congestion Due To The Common Cold
Pill Appearance
Shape: oval Color: white Imprint: PE;723

Identifiers & Packaging

Container Type UNKNOWN
UNII
362O9ITL9D 9D2RTI9KYH 495W7451VQ 6V9V2RYJ8N
Packaging

PRINCIPAL DISPLAY PANEL NDC 50991-535-01 DURAFLU™ Expectorant/ Nasal Decongestant Antitussive/Pain Reliever 100 Tablets NDC 50991-535-01 DURAFLU™ Expectorant/ Nasal Decongestant Antitussive/Pain Reliever 100 Tablets

Package Descriptions
  • PRINCIPAL DISPLAY PANEL NDC 50991-535-01 DURAFLU™ Expectorant/ Nasal Decongestant Antitussive/Pain Reliever 100 Tablets NDC 50991-535-01 DURAFLU™ Expectorant/ Nasal Decongestant Antitussive/Pain Reliever 100 Tablets

Overview

Temporarily relieves minor aches and pains fever headache cough due to minor throat and bronchial irritation helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes nasal congestion due to the common cold

Indications & Usage

Temporarily relieves minor aches and pains fever headache cough due to minor throat and bronchial irritation helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes nasal congestion due to the common cold

Dosage & Administration

Directions Adults and children 12 years of age and over: 1 tablet every 4 hours, not to exceed 6 tablets in 24 hours or as directed by a doctor Children under 12 years of age ½ tablet every 4 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor When using this product do not exceed recommended dosage.

Warnings & Precautions
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: More than 3,000 mg of acetaminophen in 24 hrs; with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not Exceed recommended dosage ■ KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN 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. Do not use this product with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor 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 ■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ■ cough that occurs with too much phlegm (mucus) 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 occur pain, cough, or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition
Purpose

Purpose Pain Reliever Antitussive Expectorant Nasal Decongestant

Do Not Use

Do not use this product with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor 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 occur pain, cough, or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur 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 THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN 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.

Questions

Questions or comments? 800-882-1041 Manufactured For: Poly Pharmaceuticals, Inc. Huntsville, AL 35763 Rev. 08/15


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