Cough and Cold XL3 Xtra by Selder, S.A. de C.V.
Dosage form: capsule, liquid filled
Ingredients: ACETAMINOPHEN 250mg, PHENYLEPHRINE HYDROCHLORIDE 5mg, CHLORPHENIRAMINE MALEATE 2mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg
Labeler: Selder, S.A. de C.V.
NDC Code: 63654-800
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 250 mg
Phenylepherine Hydrochloride 5 mg
Chlorpheniramine Maleate 2 mg
Dextromethorphan Hydrobromide 10 mg
Do not use •more than recommended dosage • for pain more than 7 days • for fever more than 3 days for children under 12 years of age • with any other product containing acetaminophen
Alcohol warning • if you consume 3 or more alcoholic drinks every day, ask your doctor if you sghould take acetaminophenor other pain relievers/fever reducers. Acetaminophen may cause liver damage
• glaucoma • breathing problem such as emphysema or chronic bronchitis • heart disease • diabetes • thyroid disease
• difficulty in urination due to enlargement of the prostate gland
Do not take this product for persistent or chronic cough such as occur with smoking, asthma or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor
Stop taking this product and ask a doctor if you have • pain • fever or symptoms that persist or get worse • new symptoms occur
• redness or swelling • these may be signs of a serious condition.
• you may get drowsy • avoid alcoholic drinks
• alcohol, sedatives and tranquilizers may increase drowsiness
• use caution when driving a motor vehicle or operating machinery
• excitability may occur, especially in children
If nervousness, dizziness or sleeplessness occur discontinue use and consult a doctor
If symptoms do not improve within 7 days, or are accompanied by fever, consult a doctor
If pregnant or breast feeding, ask a health professional before use
• Do not use if you are 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.
Directions Adults and children 12 years of age and older; take 2 capsules every 4 hours. Do not take more than 12 capsules in 24 hours, unless directed by a doctor. For children under 12 years of age, consult a doctor
Inactive Ingredients DC Red No. 33, FDC Blue No. 1, gelatin, glycerin, polyethylene glycol 600, polyethylene glycol 1000, povidone, polyethylene glycol, water
|COUGH AND COLD
acetaminophen chlorpheniramine maleate dextromethorphan hydrobromide phenylepherine hydrochloride capsule, liquid filled
|Labeler - Selder, S.A. de C.V. (824413629)|
|Progela, S.A. de C.V.||812374932||manufacture|
|Selder, S.A. de C.V.||824413629||manufacture|
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.