Guaifenesin Tablet
FDA Label NDC 16103-379

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharbest Pharmaceuticals, Inc. for the product Guaifenesin (NDC 16103-379). 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 ingredient (in each tablet), purpose, uses, warnings, stop use and ask a 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

Active Ingredient (In Each Tablet)

Guaifenesin 400mg

Purpose

Expectorant

Uses

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

Warnings

Ask doctor before use if you have

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

Stop Use And Ask A Doctor If

  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

    • These could be signs of serious illness.

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 right away (1-800-222-1222).

Directions

  • take with a full glass of water
  • this product can be administered without regard for the timing of the meals
  • do not exceed 6 doses in 24 hours or as directed by doctor

    • adults and children 12 years of age and over

    take 1 tablet every 4 hours as needed

    children 6 to under 12 years of age

    take ½ tablet every 4 hours as needed

    children under 6 years of age

    consult a doctor

Other Information

  • store at room temperature (15°-30°C)

Inactive Ingredients

magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, stearic acid.

Questions?

Adverse drug event call (866) 562-2756 Mon-Fri: 8 AM to 4 PM

Package Label.Principal Display Panel

PHARBEST 

NDC 16103-379-04

Manufactured in the USA

Immediate Release

*COMPARE TO the active ingredient in MUCINEX® Tablets

PHARBINEX

Guaifenesin 400mg each

Expectorant

30 TABLETS

* Please review the disclaimer below.