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COMTREX

Novartis Consumer Health, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




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
Age Dose
children under 4 years of age do not use
children 4 to under 12 years of age do not use unless directed by a doctor
adults and children 12 years of age and over 2 caplets

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

COMTREX

COMTREX

Acetaminophen, Chlorpheniramine Maleate, Phenylephrin HCl KIT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0067-2083
Route of Administration DEA Schedule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 1 in 1 BLISTER PACK
2 NDC:0067-2083-24 3 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2010-07-01


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Be sure to consult your doctor before taking any medication!
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