COMTREX Maximum Strength Cold and Cough Non-Drowsy

Dosage form: tablet, coated
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 15mg
Labeler: Novartis Consumer Health, Inc.
NDC Code: 0067-2077

Disclaimer: 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 Facts

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

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

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

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

Principal Display

COMTREX  MAXIMUM STRENGTH COLD AND COUGH NON-DROWSY
acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-2077
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE15 mg
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
CARNAUBA WAX 
D&C YELLOW NO. 10 
FD&C RED NO. 40 
HYPROMELLOSE 
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 CodeCx;A
Contains    
Packaging
#Item CodePackage Description
1NDC:0067-2077-242 BLISTER PACK (BLISTER PACK) in 1 CARTON
112 TABLET, COATED (BLISTER) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/08/2006
Labeler - Novartis Consumer Health, Inc. (879821635)

Revised: 12/2009
 
Novartis Consumer Health, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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