Pharbinex-pe
FDA Label NDC 16103-389

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-pe (NDC 16103-389). 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 caplet), purpose, uses, warnings, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Caplet)

Guaifenesin 400mg

Phenylephrine HCl 10mg

Purpose

Expectorant

Nasal Decongestant

Uses

Temporarily relieves symptoms associated with cough, the common cold, hay fever or upper respiratory allergies

  • helps loosen phlegm(mucus)
  • thin bronchial secretions
  • drain bronchial tubes
  • make coughs more productive
  • loosen nasal congestion
  • clear stuffy nose
  • clear nasal passageways
  • shrinks swollen membranes

Warnings

Do not exceed recommended dosage.

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 an MAOI, ask your doctor or pharmacist before using this product.

Ask A Doctor Before Use If You Have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • excessive phlegm (mucus)
  • difficulty in urination due to enlargement of prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop Use And Ask A Doctor If

  • nervousness, dizziness or sleeplessness occurs
  • symptoms are accompanied by fever, rash or persistent headache
  • cough and congestion do not improve within 7 days or tend to recur

    • These could be signs of a 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 caplet every 4 hours as needed

    children 6 to under 12 years of age

    take ½ caplet 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

croscarmellose sodium, hypromellose, lactose, magnesium stearate, maltodextrin, microcrystalline celluclose, mineral oil, povidone, silicon dioxide, sodium lauryl sulfate, stearic acid, titanium dioxide, triacetin

Questions?

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

Package Label.Principal Display Panel

PHARBEST 

NDC 16103-0389-04

Manufactured in the USA

Immediate Release

PHARBINEX-PE

Guaifenesin 400mg & Phenylephrine HCl 10mg

Expectorant & Nasal Decongestant

30 CAPLETS

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