NDC 46122-700 Gnp Mucus Relief PE

Guaifenesin/phenylephrine

NDC Product Code 46122-700

NDC CODE: 46122-700

Proprietary Name: Gnp Mucus Relief 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/phenylephrine 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: OVAL (C48345)
Size(s):
18 MM
Imprint(s):
PH043
Score: 2

NDC Code Structure

  • 46122 - Amerisourcebergen Drug Corp

NDC 46122-700-71

Package Description: 1 BOTTLE in 1 CARTON > 50 TABLET in 1 BOTTLE

NDC Product Information

Gnp Mucus Relief PE with NDC 46122-700 is a a human over the counter drug product labeled by Amerisourcebergen Drug Corp. The generic name of Gnp Mucus Relief PE is guaifenesin/phenylephrine. The product's dosage form is tablet and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1304111.

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.

Gnp Mucus Relief 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.


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 (UNII: J2B2A4N98G)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • POVIDONE (UNII: FZ989GH94E)
  • MAGNESIUM SILICATE (UNII: 9B9691B2N9)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRIACETIN (UNII: XHX3C3X673)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

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: Amerisourcebergen Drug Corp
Labeler Code: 46122
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: 08-18-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Gnp Mucus Relief PE Product Label Images

Gnp Mucus Relief 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

Otc - Active Ingredient

Active ingredient - (per tablet)Guaifenesin   400 mgPhenylephrine HCl  10 mg

Purpose

Guaifenesin.......................ExpectorantPhenylephrine HCl..............Nasal decongestant

Uses

  • Temporarily relieves symptoms associated with a cough ,the common cold,hay fever or other upper respiratory allergies.helps loosen phlegm (mucus)clear nasal passagewaysloosens nasal congestiondrain bronchial tubesshrinks swollen membranesclears stuffy nosemakes coughs more productivethin bronchial secretions

Warnings

Do not exceed recommended dosage

Do Not Use

This product 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 are uncertain whether your prescription drug contains an MAOI, ask a health professional.

Ask A Doctor Before Use If You Have

  • Heart diseasehigh blood pressurethyroid diseasediabetesexcessive phlegm;mucusdifficulty in urination due to an enlarged prostate glandpersistent or chronic cough such as occurs with smoking,asthma,chronic bronchitis or emphysema

Stop Use And Ask A Doctor If

  • Nervousness, dizziness or sleeplessness occurssymptoms are accompanied by fever, rash, persistent headache or excessive phlegm (mucus)cough and congestion do not improve within 7 days or tend to recur.These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a healthprofessional before use.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Directions

  • Adults and children 12 years and over: take 1 caplet every 4 hours as neededchildren 6 to under 12 years: take 1/2 caplet every 4 hours as neededchildren under 6 years: consult a doctorDo not exceed 6 doses in a 24 hour period or as directed by a doctor.

Inactive Ingredients

Croscarmellose sodium, Hypromellose, lactose, magnesium silicate, magnesium stearate maltodextrin, microcrystalline cellulose, mineral oil, povidone, silicon dioxide, sodium lauryl sulfate, stearic acid, titanium dioxide, triacetin

* Please review the disclaimer below.