DURAFLU- acetaminophen, dextromethorphan hbr, guaifenesin, pseudoephedrine hcl tablet

Duraflu by

Drug Labeling and Warnings

Duraflu by is a Otc medication manufactured, distributed, or labeled by Poly Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• 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

INGREDIENTS AND APPEARANCE

DURAFLU 
acetaminophen, dextromethorphan hbr, guaifenesin, pseudoephedrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50991-535
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	60 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	2 pieces
Shape	OVAL	Size	20mm
Flavor		Imprint Code	PE;723
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50991-535-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/01/2015

Labeler - Poly Pharmaceuticals, Inc. (198449894)

Establishment
Name	Address	ID/FEI	Business Operations
TG United		172837085	manufacture(50991-535)