Active Ingredients
Acetaminophen 325 mg
Dextromethorphan HBr 20 mg
Guaifenesin 200 mg
Pseudoephedrine HCl 60 mg
Duraflu Tablet
FDA Label NDC 50991-535
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Poly Pharmaceuticals, Inc. for the product Duraflu (NDC 50991-535). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, temporarily relieves, warnings, ■ keep this and all medication out of reach of children, do not use this product, ask a doctor before use if you have, ask a doctor or pharmacist before use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain Reliever
Antitussive
Expectorant
Nasal Decongestant
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
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
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.
Other Information
Store at 20°- 25° Celsius (68° – 77° Fahrenheit) as defined in the (USP/NF). Dispense in tight, light-resistant container.
Inactive Ingredients
magnesium stearate, microcrystalline cellulose, stearic acid
Questions Or Comments?
800-882-1041
Manufactured For:
Poly Pharmaceuticals, Inc.
Huntsville, AL 35763
Rev. 08/15
Principal Display Panel
NDC 50991-535-01
DURAFLU™
Expectorant/ Nasal Decongestant
Antitussive/Pain Reliever
100 Tablets
Ndc 50991-535-01duraflu™expectorant/ Nasal Decongestantantitussive/pain Reliever100 Tablets (Duraflu Tablets 01)
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