Pharbinex Tablet
FDA Label NDC 73057-379

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ulai Health Llc for the product Pharbinex (NDC 73057-379). 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, 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., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient (In Each Tablet)

Guaifenesin 400 mg

Purpose

Expectorant

Uses

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

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)

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 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 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 ask a doctor

Other Information

store at 200- 250C (680-770F)

Inactive Ingredients

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

Questions?

(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

*This product is not manufactured or distributed by Reckitt Benckiser LLC, owner of registered trademark Mucinex®

Distributed by:

ULAI HEALTH LLC.

Alexandria, VA 22312

Package Label.Principal Display Panel

PHARBEST

NDC 73057-379-04

Manufactured in the USA

Immediate Release

PHARBINEX

*Compare to the active ingredient in Mucinex® Tablets

Guaifenesin 400mg

Expectorant

30 TABLETS

* Please review the disclaimer below.