Pharbinex-dm Tablet
FDA Label NDC 16103-381

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 Pharbinex-dm (NDC 16103-381). 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), purpose, uses, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Tablet)

Guaifenesin 400mg

Dextromethorphan HBr 20mg

Purpose

Expectorant

Cough suppressant

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
  • helps make cough more productive
  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold

Warnings

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 MAOI drug. If you do not know whether your prescription drug contains MAOI, ask your doctor or pharmacist before using this product.

Ask A 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)

When Using This Product

  • do not use more than directed

Stop Use And Ask A Doctor If

  • cough lasts more than 7 days, comes back, or occure 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 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 celluclose, 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 16103-381-04

Manufactured in the USA

Immediate Release

*Compare to the active ingredient in MUCINEX® DM Tablets

PHARBINEX-DM

Guaifenesin 400mg & Dextromethorphan HBr 20mg

Expectorant & Cough Suppressant

30 TABLETS

* Please review the disclaimer below.