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

Purpose

Pain Reliever Antitussive Expectorant Nasal Decongestant

Description

DurafluTablets Rev. 08/15 Drug Facts


Medication Information

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
Purpose

Pain Reliever

Antitussive

Expectorant

Nasal Decongestant

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

Description

DurafluTablets Rev. 08/15 Drug Facts

Principal Display Panel

NDC 50991-535-01

DURAFLU™

Expectorant/ Nasal Decongestant

Antitussive/Pain Reliever

100 Tablets



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

Active Ingredients

Acetaminophen 325 mg

Dextromethorphan HBr 20 mg

Guaifenesin 200 mg

Pseudoephedrine HCl 60 mg

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
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

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
Purpose

Pain Reliever

Antitussive

Expectorant

Nasal Decongestant

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.

Inactive Ingredients (Inactive ingredients)

magnesium stearate, microcrystalline cellulose, stearic acid

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50991-535-01

DURAFLU™

Expectorant/ Nasal Decongestant

Antitussive/Pain Reliever

100 Tablets



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

Active Ingredients

Acetaminophen 325 mg

Dextromethorphan HBr 20 mg

Guaifenesin 200 mg

Pseudoephedrine HCl 60 mg

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
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.


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