Duraflu

Poly Pharmaceuticals, Inc.

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Purpose

FULL PRESCRIBING INFORMATION

Acetaminophen 500 mg
Dextromethorphan HBr 20 mg                                                                               
Guaifenesin 200 mg
Pseudoephedrine HCl 60 mg                                                                                

Purpose

Pain reliever
Antitussive
Expectorant
Nasal decongestant

Acetaminophen is an analgesic (pain reliever) and antipyretic (fever reducer).  Dextromethorphan temporarily suppresses cough due to minor bronchial irritation associated with a cold or inhaled irritants. Guaifenesin is an expectorant that helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. Pseudoephedrine is a nasal decongestant, for the temporary relief of nasal congestion due to the common cold.

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than FOUR tablets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using 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.

if you have liver disease

if you are taking the blood thinning drug warfarin.

If you are pregnant or nursing consult a doctor before using this product.

• 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

a persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.  Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor.  If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.  Do not take this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

Do not use this product 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 are uncertain whether your prescription drug contains an MAOI, consult a health professional before taking this product.

• ​If swallowed, immediately call Poison Control Center or doctor.

Dose as follows or as directed by a doctor.

Adult s and Children over 12 Years of age: one tablet four times per day not to exceed 4 tablets in 24 hours. Childre n 6 to 12 years of age : 1/2 tablet every 4 hours, not to exceed 2 tablets in 24 hours. Childre n under 6 years of age: Consult a physician.

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

Supplied in 100ct bottle, NDC 50991-0510-01.

CAUTION : Under Federal DEA law a retail outlet must store this product out of reach of customers.

Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Modified Cellulose Gum, Silicon Dioxide, Starch, Stearic Acid.

800-882-1041

Rev. 10/12

NDC 50991-0510-01
DURAFLU^™
Expectorant/ Nasal Decongestant
Antitussive/Pain Reliever
100 Tablets