ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAIFENESIN, PSEUDOEPHEDRINE HCl (Duraflu) Drug Information

Duraflu

ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAIFENESIN, PSEUDOEPHEDRINE HCl

PSEUDOEPHEDRINE HYDROCHLORIDE

PSEUDOEPHEDRINE

MAGNESIUM STEARATE

CELLULOSE, MICROCRYSTALLINE

STEARIC ACID

ACETAMINOPHEN

DEXTROMETHORPHAN HYDROBROMIDE

DEXTROMETHORPHAN

GUAIFENESIN

PE;723

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

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