Duraflu ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAIFENESIN, PSEUDOEPHEDRINE HCl ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE CARBOXYMETHYLCELLULOSE SODIUM SILICON DIOXIDE STEARIC ACID PE;723 Uses 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.

Duraflu ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAIFENESIN, PSEUDOEPHEDRINE HCl ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE CARBOXYMETHYLCELLULOSE SODIUM SILICON DIOXIDE STEARIC ACID PE;723

Mfr: OTC
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Drug Facts

Composition & Profile

Active Ingredients
Active Ingredients Acetaminophen 500 mg Dextromethorphan HBr 20 mg Guaifenesin 200 mg Pseudoephedrine HCl 60 mg
Inactive Ingredients
Inactive ingredients Hypromellose Magnesium Stearate Microcrystalline Cellulose Modified Cellulose Gum Silicon Dioxide Starch Stearic Acid.
Strengths
500 mg 20 mg 200 mg 60 mg
Quantities
100 tablets
Treats Conditions
Uses 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

Identifiers & Packaging

Container Type UNKNOWN
Packaging

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

Package Descriptions
  • Principal Display Panel NDC 50991-0510-01 DURAFLU ™ Expectorant/ Nasal Decongestant Antitussive/Pain Reliever 100 Tablets NDC 50991-0510-01 DURAFLU™ Expectorant/ Nasal Decongestant Antitussive/Pain Reliever 100 Tablets

Overview

Uses 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.

Indications & Usage

Uses 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.

Dosage & Administration

Directions 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.

Warnings & Precautions
Warnings 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
Purpose

Purpose Pain reliever Antitussive Expectorant Nasal decongestant

Do Not Use

Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

When Using

When using this product 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.

Stop Use & Ask a Doctor

Stop use and ask a doctor if 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

Keep Out of Reach of Children

Keep out of reach of children ​If swallowed, immediately call Poison Control Center or doctor.

Storage & Handling

Other information 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.

Questions

Questions or comments? 800-882-1041 Manufactured For: Poly Pharmaceuticals, Inc. Quitman, MS 39355 Rev. 10/12


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