Duraflu Tablets

Duraflu Tablets
SPL v8
SPL
SPL Set ID 55fffc1d-8449-4c28-a391-c6f60dd85622
Route
ORAL
Published
Effective Date 2015-10-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pseudoephedrine (60 mg) Acetaminophen (325 mg) Dextromethorphan (20 mg) Guaifenesin (200 mg)
Inactive Ingredients
Magnesium Stearate Cellulose, Microcrystalline Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: PE;723 Shape: oval Color: white Size: 20 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-10-01

Description

DurafluTablets Rev. 08/15 Drug Facts

Purpose

Pain Reliever Antitussive Expectorant Nasal Decongestant


Medication Information

Purpose

Pain Reliever

Antitussive

Expectorant

Nasal Decongestant

Description

DurafluTablets Rev. 08/15 Drug Facts

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.

Section 42229-5

DurafluTablets

Rev. 08/15

Drug Facts

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
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.

Active Ingredients

Acetaminophen 325 mg

Dextromethorphan HBr 20 mg

Guaifenesin 200 mg

Pseudoephedrine HCl 60 mg

Inactive Ingredients

magnesium stearate, microcrystalline cellulose, stearic acid

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
Questions Or Comments?

800-882-1041

Manufactured For:

Poly Pharmaceuticals, Inc.

Huntsville, AL 35763

Rev. 08/15

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
Principal Display Panel

NDC 50991-535-01

DURAFLU™

Expectorant/ Nasal Decongestant

Antitussive/Pain Reliever

100 Tablets



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

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.


Structured Label Content

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.

Section 42229-5 (42229-5)

DurafluTablets

Rev. 08/15

Drug Facts

Purpose

Pain Reliever

Antitussive

Expectorant

Nasal Decongestant

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
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 (Other information)

Store at 20°- 25° Celsius (68° – 77° Fahrenheit) as defined in the (USP/NF). Dispense in tight, light-resistant container.

Active Ingredients

Acetaminophen 325 mg

Dextromethorphan HBr 20 mg

Guaifenesin 200 mg

Pseudoephedrine HCl 60 mg

Inactive Ingredients (Inactive ingredients)

magnesium stearate, microcrystalline cellulose, stearic acid

Temporarily Relieves (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
Questions Or Comments? (Questions or comments?)

800-882-1041

Manufactured For:

Poly Pharmaceuticals, Inc.

Huntsville, AL 35763

Rev. 08/15

Do Not Use This Product (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
Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50991-535-01

DURAFLU™

Expectorant/ Nasal Decongestant

Antitussive/Pain Reliever

100 Tablets



When Using This Product (When using this product)

do not exceed recommended dosage.

Stop Use and Ask A Doctor If (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

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use)

if you are taking the blood thinning drug warfarin.


Advanced Ingredient Data


Raw Label Data

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