COMTREX

Novartis Consumer Health, Inc.

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient
• Ask a doctor or pharmacist before use if you are
• Purpose
• COMTREX Uses
• Warnings
• Do Not Use
• Ask a doctor before use if you have
• Ask Doctor or Pharmacist before use if you are
• When using this product
• Stop Use and ask a doctor if
• If pregnant or breast-feeding,
• Keep Out of Reach of Children
• Directions
• COMTREX Other information
• Inactive ingredients
• Questions or comments?
• Principal Display

FULL PRESCRIBING INFORMATION

Active ingredient

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Ask a doctor or pharmacist before use if you are

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

COMTREX Uses

• temporarily relieve

• headache • sore throat pain

• minor aches and pains • nasal and sinus congestion

• cough due to minor throat and bronchial irritation as may occur with a cold

• temporarily reduces fever

Warnings

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

• more than 12 caplets 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

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly.

Do Not Use

• in a child under 4 years of age
• if you are allergic to acetaminophen
• 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 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 • diabetes

• cough that occurs with too much phlegm (mucus) • thyroid disease

• cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

• trouble urinating due to an enlarged prostate gland

Ask 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

• you get nervous, dizzy, or sleepless • new symptoms occur

• redness or swelling is present • symptoms do not get better or worsen

• fever gets worse or lasts more than 3 days

• pain, cough or nasal congestion gets worse or lasts more than 7 days

• cough comes back or occurs with a fever, rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health care professional before use.

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not use more than directed

 • take every 4 hours, while symptoms persist

• do not take more than12 caplets in 24 hours

COMTREX Other information

• store at controlled room temperature 20-25°C (68-77°F)

Inactive ingredients

benzoic acid, carnauba wax, D&C yellow #10 lake, FD&C red #40 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

call 1-800-452-0051

Distributed by: Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622

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