Your browser does not support JavaScript! COMTREX MAXIMUM STRENGTH DAY / NIGHT SEVERE COLD AND SINUS (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRIN HCL) KIT [NOVARTIS CONSUMER HEALTH, INC.]
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COMTREX MAXIMUM STRENGTH DAY / NIGHT SEVERE COLD AND SINUS (acetaminophen, chlorpheniramine maleate, phenylephrin hcl) kit
[Novartis Consumer Health, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

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

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
AgeDose
children under 4 years of agedo not use
children 4 to under 12 years of agedo not use unless directed by a doctor
adults and children 12 years of age and over2 caplets

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

Carton Image

COMTREX  MAXIMUM STRENGTH DAY / NIGHT SEVERE COLD AND SINUS
acetaminophen, chlorpheniramine maleate, phenylephrin hcl kit
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0067-2083
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-2083-243 in 1 CARTON
11 in 1 BLISTER PACK
Quantity of Parts
Part #Package QuantityTotal 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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorORANGE (Orange) Scoreno score
ShapeCAPSULE (Capsule shaped tablet) Size18mm
FlavorImprint Code CxC
Contains    
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/2010
Part 2 of 2
COMTREX  MAXIMUM STRENGTH NIGHTTIME SEVERE COLD AND SINUS
acetaminophen, chlorpheniramine maleate, phenylephrin hcl tablet, film coated
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE2 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorGREEN (Green) Scoreno score
ShapeCAPSULE (capsule shaped tablet) Size18mm
FlavorImprint Code CxS
Contains    
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/01/2010
Labeler - Novartis Consumer Health, Inc. (879821635)
Establishment
NameAddressID/FEIBusiness Operations
Novartis Consumer Health129836151MANUFACTURE

Revised: 10/2010
 
Novartis Consumer Health, Inc.

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