Drug Facts
Drug Labeling and Warnings
Drug Details [pdf]
COMTREX MAXIMUM STRENGTH COLD AND COUGH NON-DROWSY- acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, coated
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
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.
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Drug Facts
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
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
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
|
Age |
Dose |
|
children under 4 years of age |
do not use |
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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 |
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
| COMTREX
MAXIMUM STRENGTH COLD AND COUGH NON-DROWSY
acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, coated |
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| Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263) |
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