Gelusil

Alumina, Magnesia, Simethicone

Wellspring Pharmaceutical Corporation
Human Otc Drug
NDC 65197-300

Gelusil also known as Alumina, Magnesia, Simethicone is a human otc drug labeled by 'Wellspring Pharmaceutical Corporation'. National Drug Code (NDC) number for Gelusil is 65197-300. This drug is available in dosage form of Tablet, Chewable. The names of the active, medicinal ingredients in Gelusil drug includes Aluminum Hydroxide - 200 mg/1 Dimethicone - 24 mg/1 Magnesium Hydroxide - 200 mg/1 Silicon Dioxide - 1 mg/1 . The currest status of Gelusil drug is Active.

Drug Information:

Drug NDC:	65197-300
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Gelusil
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Alumina, Magnesia, Simethicone
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Wellspring Pharmaceutical Corporation
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Tablet, Chewable
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	ALUMINUM HYDROXIDE - 200 mg/1 DIMETHICONE - 24 mg/1 MAGNESIUM HYDROXIDE - 200 mg/1 SILICON DIOXIDE - 1 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	OTC MONOGRAPH FINAL
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	24 Sep, 2008
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	18 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	part331
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.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	WellSpring Pharmaceutical Corporation
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	211633 307747
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UPC:	0365197300112
UPC stands for Universal Product Code.
NUI:	N0000010282
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	5QB0T2IUN0 92RU3N3Y1O NBZ3QY004S ETJ7Z6XBU4
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class PE:	Skin Barrier Activity [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class:	Calculi Dissolution Agent [EPC] Increased Large Intestinal Motility [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Inhibition Small Intestine Fluid/Electrolyte Absorption [PE] Magnesium Ion Exchange Activity [MoA] Osmotic Activity [MoA] Osmotic Laxative [EPC] Skin Barrier Activity [PE] Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
65197-300-10	10 BLISTER PACK in 1 CARTON (65197-300-10) / 10 TABLET, CHEWABLE in 1 BLISTER PACK	24 Sep, 2008	N/A	No
65197-300-11	100 TABLET, CHEWABLE in 1 BOTTLE (65197-300-11)	01 Dec, 2018	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Gelusil

Alumina, Magnesia, Simethicone

Tablet, Chewable
WellSpring Pharmaceutical Corporation
NDC: 65197-300

Purpose:

Purpose active ingredients (in each tablet) purpose aluminum hydroxide dried gel 200 mg........................antacid magnesium hydroxide 200 mg....................................antacid simethicone 25 mg......................................................antigas

Product Elements:

Gelusil alumina, magnesia, simethicone aluminum hydroxide aluminum hydroxide magnesium hydroxide magnesium cation dimethicone dimethicone silicon dioxide silicon dioxide dextrose, unspecified form magnesium stearate maltodextrin sucralose silicon microcrystalline cellulose pd;gelusil;034

Indications and Usage:

Uses relieves: â¢ heartburn â¢ sour stomach â¢ acid indigestion â¢ bloating, pressure and discomfort commonly referred to as gas

Warnings:

Warnings ask a doctor before use if you have â¢ kidney disease â¢ a magnesium restricted diet ask a doctor or pharmacist before use if you are now taking a prescription drug. antacids may interact with certain prescription drugs. stop use and ask a doctor if symptoms last more than 2 weeks 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 if pregnant or breastfeeding ask a health professional before use.

Dosage and Administration:

Directions â¢ adults and children 12 years of age and older: chew 2 to 4 tablets. repeat hourly if symptoms return, or as directed by a physician â¢ children under 12 of age: ask a doctor â¢ do not take more than 12 tablets in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician

Stop Use:

Stop use and ask a doctor if symptoms last more than 2 weeks

Package Label Principal Display Panel:

Principal display panel - carton gelusil antacid 100 chewable tablets gelusil antacid antigas cool mint 100 chewable tablets gelusil antacid antigas 10 blisters

Further Questions:

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.