Label: COMTREX MAXIMUM STRENGTH DAY / NIGHT SEVERE COLD AND SINUS- acetaminophen, chlorpheniramine maleate, phenylephrin hcl   

  • Label RSS
  • NDC Code(s): 0067-2083-24
  • Packager: Novartis Consumer Health, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 10/10

If you are a consumer or patient please visit this version.

  • Active ingredient

    Acetaminophen 325 mg

    Chlorpheniramine maleate 2 mg*

    Phenylephrine HCl 5 mg

    * antihistamine in nighttime dose only

    Close
  • Purpose

    Pain reliever / fever reducer

    Antihistamine*

    Nasal decongestant

    Close
  • 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
    Close
  • 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.

    Close
  • 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.
    Close
  • 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
    Close
  • Ask a doctor or pharmacist before use if you are taking

    • sedatives or tranquilizers
    • the blood thinning drug warfarin
    Close
  • 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
    Close
  • 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
    Close
  • If pregnant or breast-feeding

    ask a health care professional before use.

    Close
  • 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.

    Close
  • 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
    Close
  • Other information

    • store at controlled room temperature 20-25° C (68-77° F)
    Close
  • 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.
    Close
  • Questions or comments?

    call 1-800-452-0051

    Close
  • Package/Label Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    COMTREX  MAXIMUM STRENGTH DAY / NIGHT SEVERE COLD AND SINUS
    acetaminophen, chlorpheniramine maleate, phenylephrin hcl kit
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0067-2083
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0067-2083-24 3 in 1 CARTON
    1 1 in 1 BLISTER PACK
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 12 
    Part 2 12 
    Part 1 of 2
    COMTREX  MAXIMUM STRENGTH DAYTIME SEVERE COLD AND SINUS
    acetaminophen, phenylephrin hcl tablet, film coated
    Product Information
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    BENZOIC ACID  
    CARNAUBA WAX  
    D&C YELLOW NO. 10  
    FD&C RED NO. 40  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOL  
    POLYSORBATE 80  
    STARCH, CORN  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color ORANGE (Orange) Score no score
    Shape CAPSULE (Capsule shaped tablet) Size 18mm
    Flavor Imprint Code CxC
    Contains     
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 07/01/2010
    Part 2 of 2
    COMTREX  MAXIMUM STRENGTH NIGHTTIME SEVERE COLD AND SINUS
    acetaminophen, chlorpheniramine maleate, phenylephrin hcl tablet, film coated
    Product Information
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
    CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 2 mg
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    BENZOIC ACID  
    CARNAUBA WAX  
    D&C YELLOW NO. 10  
    FD&C BLUE NO. 1  
    FD&C RED NO. 40  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    STARCH, CORN  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color GREEN (Green) Score no score
    Shape CAPSULE (capsule shaped tablet) Size 18mm
    Flavor Imprint Code CxS
    Contains     
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 07/01/2010
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 07/01/2010
    Labeler - Novartis Consumer Health, Inc. (879821635)
    Establishment
    Name Address ID/FEI Business Operations
    Novartis Consumer Health 129836151 MANUFACTURE
    Close