Pharbinex-pe Tablet, Coated
FDA Label NDC 73057-389

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ulai Health Llc for the product Pharbinex-pe (NDC 73057-389). 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, do not use, ask a doctor before use if you have, otc - when using, 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 Caplet)

Guaifenesin 400mg

Phenylephrine HCl 10mg

Purpose

Expectorant

Nasal decongestant

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
  • helps to make cough more productive
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • promotes nasal and/or sinus drainage
  • temporarily relieves sinus congestion and pressure

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 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

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to an enlarged prostate gland
  • cough accompanied by too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Otc - When Using

When using this product do not exceed recommended dosage.

Stop Use And Ask A Doctor If

  • nervousness, dizziness or sleeplessness occurs
  • symptoms do not improve within 7 days, or are accompanied by a fever
  • cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, persistent headache

    • These could be sings 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 the meals
  • do not exceed 6 doses in 24 hours or as directed by a 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

    ask a doctor

Other Information

store at 200- 250C (680-770F)

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 Or Comments?

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

Other

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by:

ULAI HEALTH LLC.

Alexandria, VA 22312

Package Label.Principal Display Panel

PHARBEST 

NDC 73057-389-04

Manufactured in the USA

Immediate Release

PHARBINEX-PE

Guaifenesin 400mg

Phenylephrine HCl 10mg

Expectorant & 

Nasal Decongestant

30 CAPLETS

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