Mucinex Fast-max Severe Cold
FDA Label NDC 51013-409

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Puracap Pharmaceutical Llc for the product Mucinex Fast-max Severe Cold (NDC 51013-409). 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 softgel), purposes, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, overdose warning:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Softgel)

Acetaminophen 325 mg 

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

  • temporarily relieves common cold/flu symptoms:
  • nasal congestion
  • headache
  • cough
  • minor aches and pains
  • sore throat
  • temperarily reduces fever
  • promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than12 liquid gels 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

    • Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

      • If a skin reaction occurs, stop use and seek medical help right away.

      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

  • 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
  • diabetes
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)

Stop Use And Ask A Doctor If

  • nervousness, dizziness, or sleeplessness occur
  • 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.

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.

Directions

  • Do not take more than directed (see Overdose warning)
  • do not exceed more than 12 liquid gels in any 24-hour period
  • adults and children 12 years of age and older: take 2 liquid gels every 4 hours
  • children under 12 years of age: do not use

Other Information

  • store between 20-25°C (68-77°F)  
  • avoid excessive heat

Inactive Ingredients

FD&C yellow no. 6, gelatin, glycerin, lecithin (soy), mineral oil,  polyethylene glycol,  povidone, propylene glycol, sorbitol, titanium dioxide, water

Questions?

1-866-MUCINEX (1-866-682-4639)

Principal Display Panel

MUCINEX FAST-MAX SEVERE COLD 16 LIQUID GELS

NDC 51013-409-14

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