NDC 73057-379 Pharbinex

Guaifenesin 400mg

NDC Product Code 73057-379

NDC 73057-379-04

Package Description: 30 TABLET in 1 BOTTLE, PLASTIC

NDC Product Information

Pharbinex with NDC 73057-379 is a a human over the counter drug product labeled by Ulai Health Llc. The generic name of Pharbinex is guaifenesin 400mg. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Ulai Health Llc

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Pharbinex Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • GUAIFENESIN 400 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POVIDONE K30 (UNII: U725QWY32X)
  • POVIDONE K90 (UNII: RDH86HJV5Z)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STEARIC ACID (UNII: 4ELV7Z65AP)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Ulai Health Llc
Labeler Code: 73057
FDA Application Number: part341 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-26-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Pharbinex Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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 mucushelps 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 emphysemacough 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 waterthis product can be administered without regard for the timing of the mealsdo 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

* Please review the disclaimer below.