Duraflu
ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAIFENESIN, PSEUDOEPHEDRINE HCl · Tablet · Oral
Active ingredient
Active Ingredients Acetaminophen 325 mg Dextromethorphan HBr 20 mg Guaifenesin 200 mg Pseudoephedrine HCl 60 mg
Purpose
Purpose Pain Reliever Antitussive Expectorant Nasal Decongestant
Uses
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
Warnings
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
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
Ask a doctor before use
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
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
When using this product
When using this product do not exceed recommended dosage.
Stop use and 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.
Directions
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.
Inactive ingredients
Inactive ingredients magnesium stearate, microcrystalline cellulose, stearic acid
Questions?
Questions or comments? 800-882-1041 Manufactured For: Poly Pharmaceuticals, Inc. Huntsville, AL 35763 Rev. 08/15
Label text from the FDA structured product label by Poly Pharmaceuticals, Inc. (revised Nov 9, 2024). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Pseudoephedrine Hydrochloride in 1 product
- Acetaminophen in 1 product
- Dextromethorphan Hydrobromide in 1 product
- Guaifenesin in 1 product
Duraflu NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50991-535 | Pseudoephedrine Hydrochloride 60 mg/1; Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 20 mg/1; Guaifenesin 200… Tablet | Poly Pharmaceuticals, Inc. | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Duraflu used for?
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
Who makes Duraflu?
Duraflu is listed by 1 labeler in the FDA NDC directory, including Poly Pharmaceuticals, Inc..