DURAFLU- acetaminophen, dextromethorphan hbr, guaifenesin, pseudoephedrine hcl tablet 
Poly Pharmaceuticals, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Duraflu Tablets

DurafluTablets

Rev. 08/15

Drug Facts

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

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take:

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 50991-535-01
DURAFLU™
Expectorant/ Nasal Decongestant
Antitussive/Pain Reliever
100 Tablets

DURAFLU 
acetaminophen, dextromethorphan hbr, guaifenesin, pseudoephedrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50991-535
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeOVALSize20mm
FlavorImprint Code PE;723
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50991-535-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/01/2015
2NDC:50991-535-026 in 1 CARTON10/01/2015
22 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/01/2015
Labeler - Poly Pharmaceuticals, Inc. (198449894)

Revised: 1/2024
Document Id: 0ff2ffe0-e7cc-b361-e063-6294a90a5148
Set id: 55fffc1d-8449-4c28-a391-c6f60dd85622
Version: 6
Effective Time: 20240127
 
Poly Pharmaceuticals, Inc.