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Duraflu (acetaminophen 325 mg dextromethorphan hydrobromide 20 mg guaifenesin 200 mg pseudoephedrine hydrochloride 60 mg) Dailymed

  1. Human OTC
  2. Uncompetitive N-methyl-D-aspartate Receptor Antagonist
  3. Poly Pharmaceuticals, Inc.

Generic: acetaminophen, dextromethorphan hbr, guaifenesin, pseudoephedrine hcl is used for the treatment of Cough Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain Bronchitis Common Cold Laryngitis Pharyngitis Rhinitis, Allergic, Perennial Sinusitis Whooping Cough Asthma

Duraflu tablet - (acetaminophen 325 mg dextromethorphan hydrobromide 20 mg guaifenesin 200 mg pseudoephedrine hydrochloride 60 mg) image

  1. FDA Adverse Reactions

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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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
  • skin reddening
  • bulers
  • 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


â–  liver disease â–  heart disease â–  high blood pressure â–  thyroid disease â–  diabetes â–  trouble urinating â–  due to an enlarged prostate gland â–  persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema â–  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



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