Active Ingredients (In Each Tablet)
Guaifenesin 400mg
Dextromethorphan HBr 20mg
Mucus Relief Xpect Tablet
FDA Label NDC 63654-342
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Selder, S.a. De C.v. for the product Mucus Relief Xpect (NDC 63654-342). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each tablet), purposes, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you, stop use and ask a doctor if, pregnancy/breastfeeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Expectorant
Cough suppressant
Uses
■ helps loosen phlegm (mucus) ■ helps thin bronchial secretions to make coughs more productive ■ temporarily relieves cough due to minor sore throat and bronchial irritation associated with the common cold.
Do Not Use
■ 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 a MAOI, ask a doctor or pharmacist before taking this product.
Ask A Doctor Before Use If You Have
■ cough accompanied by excessive phlegm (mucus) ■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema.
Ask A Doctor Or Pharmacist Before Use If You
■ are taking sedatives or tranquilizers.
Stop Use And Ask A Doctor If
■ cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache.
These could be signs of a serious condition.
Pregnancy/Breastfeeding
If pregnant or breast-feeding, ask a health professional before use.
Keep Out Of Reach Of Children
Keep out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Directions
Adults and children 12 years and older: take 1 tablet every 4 hours with a full glass of water while symptoms persist. ■ Do not exceed 6 doses in 24 hours. Children under 12 years of age: do not use.
Other Information
■ store at 25°C (77°F) excursions between 15°-30°C (59°-86°F) ■ Keep in a dry place and do not expose to heat ■ do not use if blister package is torn or damaged.
Inactive Ingredients
alcohol, colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate (derived from milk), magnesium stearate, polyethylene glycol, povidone, purified water, stearic acid
Questions Or Comments?
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Package Label
Package Label (Xl3xpect)
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