Refenesen Mucus Relief Tablet
FDA Label NDC 10956-845

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Reese Pharmaceutical Co for the product Refenesen Mucus Relief (NDC 10956-845). 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 otc - active ingredient, purpose, uses, warnings, stop use and ask doctor if, if pregnant or breast-feeding, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient


Active ingredient (per tablet)

Guaifenesin  400mg

Purpose

Expectorant

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus 
  • helps make coughs more productive

Warnings

Ask doctor before use if you have

  • persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysema
  • cough is accompanied by excessive phlegm (mucus)

Stop Use And Ask Doctor If

  • Symptoms are accompanied by fever, rash or persistent headache
  • cough persists for more than 1 week or tends to recur

    • A persistent cough may be a sign of a serious condition.

If Pregnant Or Breast-Feeding

Ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control
Center immediately.

Directions

  • Adults and children 12 years of age and over: take 1 tablet every 4 hours as needed
  • Children 6 to 10 under 12 years of age: take 1/2 tablet every 4 hours as needed
  • Children under 6 years of age: consult a doctor    
    • Do not exceed 6 doses in a 24 hour period or as directed by a doctor

Other Directions

store at 15°-30°C (59°-86°F)

Inactive Ingredients

Magnesium Stearate, Microcrystalline Cellulose. Silicon Dioxide, Maltodextrin,  Stearic acid, Povidone K30, Povidone 90F

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