COMTREX

Novartis Consumer Health, Inc.

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient
• Purpose
• COMTREX Uses
• Warnings
• Do not use
• Ask a doctor before use if you have
• Ask a doctor or pharmacist before use if you are taking
• 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?
• Package/Label Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg*

Phenylephrine HCl 5 mg

* antihistamine in nighttime dose only

Purpose

Pain reliever / fever reducer

Antihistamine*

Nasal decongestant

COMTREX Uses

• daytime (orange caplets) - temporarily relieves:
  • minor aches and pains
  • headaches
  • nasal congestion
  • sinus congestion & pressure
• nighttime (green caplets) - provides the same relief as the daytime caplets plus temporarily relieves:
  • runny nose
  • sneezing

Warnings

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

• more than 12 caplets (8 daytime & 4 nighttime total) 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 warnings: 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
• glaucoma
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostrate gland
• a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are taking

• sedatives or tranquilizers
• the blood thinning drug warfarin

When using this product

• do not exceed recommended dosage
• when using nighttime product:
  • drowsiness may occur
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be carful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• new symptoms occur
• you get nervous, dizzy, or sleepless
• redness or swelling is present
• pain or nasal congestion gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days

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
  • daytime - orange caplets - take every 4 hours, while symptoms persist
  • do not take more than 8 daytime caplets in 24 hours, unless directed by a doctor

  • nighttime - green caplets - take no sooner than 4 hours after the last daytime dose
  • wait at least 4 hours before taking an additional nighttime dose, if needed
  • do not take more than 4 nighttime caplets in 24 hours, unless directed by a doctor

COMTREX Other information

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

Inactive ingredients

• daytime caplet - 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.
• nighttime caplet - benzoic acid, carnauba wax, D&C yellow #10 lake, FD&C blue #1 lake, FD&C red #40 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, stearic acid, titanium dioxide.

Questions or comments?

call 1-800-452-0051

Package/Label Principal Display Panel