COMTREX Maximum Strength Cold and Cough Non-Drowsy Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE BENZOIC ACID CARNAUBA WAX D&C YELLOW NO. 10 FD&C RED NO. 40 HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 STARCH, CORN STEARIC ACID TITANIUM DIOXIDE Orange Capsule shaped tablet Cx;A
Drug Facts
Composition & Profile
Identifiers & Packaging
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Overview
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
Indications & Usage
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
Dosage & Administration
Directions • do not use more than directed • take every 4 hours, while symptoms persist • do not take more than12 caplets in 24 hours 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
Warnings & Precautions
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.
Purpose
Purpose Pain reliever / fever reducer Cough suppressant Nasal decongestant
Do Not Use
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.
When Using
When using this product • do not exceed recommended dosage
Stop Use & Ask a Doctor
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.
Keep Out of Reach of Children
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.
Storage & Handling
Other information • store at controlled room temperature 20-25°C (68-77°F)
Questions
Questions or comments? call 1-800-452-0051 Distributed by: Novartis Consumer Health, Inc. Parsippany, NJ 07054-0622
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