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.
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Pain reliever/fever reducer
• 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
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.
- 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.
• 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
• taking the blood thinning drug warfarin
• do not exceed recommended dosage
• 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.
ask a health care professional before use.
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.
• do not use more than directed
• take every 4 hours, while symptoms persist
• do not take more than12 caplets in 24 hours
|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|
• store at controlled room temperature 20-25°C (68-77°F)
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
Distributed by: Novartis Consumer Health, Inc.
Parsippany, NJ 07054-0622
MAXIMUM STRENGTH COLD AND COUGH NON-DROWSY
acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, coated
|Labeler - Novartis Consumer Health, Inc. (879821635)|
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.