NDC 73057-389 Pharbinex-pe

Guaifenesin 400mg And Phenylephrine Hcl 10mg

NDC Product Code 73057-389

NDC Code: 73057-389

Proprietary Name: Pharbinex-pe What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Guaifenesin 400mg And Phenylephrine Hcl 10mg What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: CAPSULE (C48336)
Size(s):
19 MM
Imprint(s):
PH043
Score: 2

NDC Code Structure

  • 73057 - Ulai Health Llc
    • 73057-389 - Pharbinex-pe

NDC 73057-389-04

Package Description: 30 TABLET, COATED in 1 BOTTLE, PLASTIC

NDC Product Information

Pharbinex-pe with NDC 73057-389 is a a human over the counter drug product labeled by Ulai Health Llc. The generic name of Pharbinex-pe is guaifenesin 400mg and phenylephrine hcl 10mg. The product's dosage form is tablet, coated and is administered via oral form.

Labeler Name: Ulai Health Llc

Dosage Form: Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.

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-pe 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
  • PHENYLEPHRINE HYDROCHLORIDE 10 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.

  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • POVIDONE K30 (UNII: U725QWY32X)
  • POVIDONE K90 (UNII: RDH86HJV5Z)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRIACETIN (UNII: XHX3C3X673)

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: 07-18-2019 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.

Information for Patients

Guaifenesin

Guaifenesin is pronounced as (gwye fen' e sin)

Why is guaifenesin medication prescribed?
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a cla...
[Read More]
Phenylephrine

Phenylephrine is pronounced as (fen il ef' rin)
Why is phenylephrine medication prescribed?
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will ...
[Read More]

* Please review the disclaimer below.

Pharbinex-pe 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 Ingredients (In Each Caplet)

Guaifenesin 400mgPhenylephrine HCl 10mg

Purpose

ExpectorantNasal decongestant

Uses

  • Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucushelps to make cough more productivetemporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergiespromotes nasal and/or sinus drainagetemporarily 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 diseasehigh blood pressurethyroid diseasediabetesdifficulty in urination due to an enlarged prostate glandcough 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 occurssymptoms do not improve within 7 days, or are accompanied by a fevercough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, persistent headacheThese 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 doctoradults and children 12 years of age and overtake 1 caplet every 4 hours as neededchildren 6 to under 12 years of agetake ½ caplet every 4 hours as neededchildren under 6 years of ageask 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

Other

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSINGDistributed by:ULAI HEALTH LLC.Alexandria, VA 22312

* Please review the disclaimer below.

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