COUGH AND COLD XL3 XTRA- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride capsule, liquid filled
Selgel México, S.A. de C.V.
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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Acetaminophen 250 mg
Chlorpheniramine Maleate 2 mg
Dextromethorphan Hydrobromide 10 mg
Phenylepherine Hydrochloride 5 mg
Pain reliever/fever reducer
Antihistamine
Antitussive (cough suppressant)
Nasal decongestant
temporarily relieves: ▪ minor aches and pains ▪ headache ▪ temporarily reduces fever ▪ runny nose ▪ sneezing ▪ itching of the nose or throat
▪ itchy, watery eyes due to hay fever or other upper respiratory allergies ▪ nasal congestion ▪ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take ▪ more than 12 capsules 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
Do not exceed recommended dosage
▪ 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 allergic to acetaminophen or any of the inactive ingredients in this product •in excess of recommended dosage ▪ 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 ▪ for persistent or chronic cough such as occurs when smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor ▪if you are taking sedatives or tranquilizers, without first consulting your doctor.
▪ liver disease ▪ a breathing problem such as emphysema or chronic bronchitis ▪ glaucoma ▪ heart disease ▪ high blood pressure
▪ thyroid disease ▪ diabetes ▪ difficulty in urination due enlargement of the prostate gland.
▪ excitability may occur, especially in children ▪ may cause drowsiness ▪ alcohol, sedatives and tranquilizers may increase drowsiness effect
▪ use caution when driving a motor vehicle or operating machinery ▪ avoid alcoholic beverages
▪ pain, nasal congestion or cough gets worse or lasts more than 7 days ▪ fever gets worse or lasts more than 3 days ▪ redness or swelling is present ▪ new symptoms occur ▪ cough comes back or occurs with rash or headache that lasts.These could be signs of a serious condition. ▪ nervousness, dizziness, or sleeplessness occur.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
▪ do not take more than directed (see overdose warning) ▪ do not use for more than 10 days unless directed by a doctor ▪ Adults and children 12 years of age and over ▪ take 2 capsule every 4 hours. ▪ do not take more than 12 capsules in 24 hours ▪ Children under 12 years of age ▪ do not use this adult product in children under 12 years of age; this will provide more than recommended dose (overdoes) and may cause liver damage.
COUGH AND COLD
XL3 XTRA
acetaminophen chlorpheniramine maleate dextromethorphan hydrobromide phenylepherine hydrochloride capsule, liquid filled |
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Labeler - Selgel México, S.A. de C.V. (812296782) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Selgel México, S.A. de C.V. | 812296782 | manufacture(58596-001) |