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  5. Label Information: Duraflu

FDA Label for Duraflu

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. TEMPORARILY RELIEVES
    4. WARNINGS
    5. ■ KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN
    6. DO NOT USE THIS PRODUCT
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. ASK A DOCTOR OR PHARMACIST BEFORE USE
    9. WHEN USING THIS PRODUCT
    10. STOP USE AND ASK A DOCTOR IF
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL

Duraflu Product Label

The following document was submitted to the FDA by the labeler of this product Poly Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients



Acetaminophen 325 mg
Dextromethorphan HBr 20 mg
Guaifenesin 200 mg
Pseudoephedrine HCl 60 mg


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 age½ 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

NDC 50991-535-01DURAFLU™Expectorant/ Nasal DecongestantAntitussive/Pain Reliever100 Tablets - duraflu tablets 01



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