Gelusil Tablet, Chewable
NDC 65197-300

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 65197-300?
  5. Gelusil Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

Gelusil (alumina, magnesia, simethicone) is a OTC MONOGRAPH DRUG-approved product labeled by Wellspring Pharmaceutical Corporation. This medication is typically used as a calculi dissolution agent [epc]. It is supplied as a white tablet, chewable for oral administration. This product entry covers the primary NDC 65197-300 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
65197-300
Proprietary Name:
Gelusil
Non-Proprietary Name: [1]
Alumina, Magnesia, Simethicone
Substance Name: [2]
Aluminum Hydroxide; Dimethicone, Unspecified; Magnesium Hydroxide; Silicon Dioxide
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Wellspring Pharmaceutical Corporation
Labeler Code:
65197
Product Label ID:
92fbeec1-1562-40f3-9734-41f133d494f9
FDA Application Number: [6]
M001
Marketing Category: [8]
OTC MONOGRAPH DRUG

Marketing Timeline

Start Marketing Date: [9]
09-24-2008
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
16 MM
Imprint(s):
PD;GELUSIL;034
Score:
1
Flavor(s):

Code Structure Chart

Product Details

What is NDC 65197-300?

The NDC code 65197-300 is assigned by the FDA to the product Gelusil. It is commonly known by its generic name, alumina, magnesia, simethicone. This pharmaceutical product is labeled by Wellspring Pharmaceutical Corporation and is currently categorized as listed product. The medication is a tablet, chewable administered via oral route. In terms of distribution, this product is available in 3 different package configurations. The associated package NDC(s) include: 65197-300-10, 65197-300-11, 65197-300-20. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

•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 •Children under 12 of age: ask a doctor•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

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • ALUMINUM HYDROXIDE 200 mg/1 - A compound with many biomedical applications: as a gastric antacid, an antiperspirant, in dentifrices, as an emulsifier, as an adjuvant in bacterins and vaccines, in water purification, etc.
  • DIMETHICONE, UNSPECIFIED 24 mg/1
  • MAGNESIUM HYDROXIDE 200 mg/1 - An inorganic compound that occurs in nature as the mineral brucite. It acts as an antacid with cathartic effects.
  • SILICON DIOXIDE 1 mg/1 - Transparent, tasteless crystals found in nature as agate, amethyst, chalcedony, cristobalite, flint, sand, QUARTZ, and tridymite. The compound is insoluble in water or acids except hydrofluoric acid.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

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. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 211633 - Gelusil Antacid & Anti-Gas 200 MG / 200 MG / 25 MG Chewable Tablet
  • RxCUI: 211633 - aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 25 MG Chewable Tablet [Gelusil]
  • RxCUI: 211633 - Gelusil (aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 25 MG) Chewable Tablet
  • RxCUI: 211633 - Gelusil Antacid & Anti-Gas (aluminum hydroxide 200 MG / milk of magnesia 200 MG / simethicone 25 MG) Chewable Tablet
  • RxCUI: 307747 - aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 25 MG Chewable Tablet

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the full disclaimer at the bottom of this page.

Patient Education

Aluminum Hydroxide


Aluminum hydroxide is used for the relief of heartburn, sour stomach, and peptic ulcer pain and to promote the healing of peptic ulcers.
[Learn More]


Magnesium Hydroxide


Magnesium hydroxide is used to treat occasional constipation in children and adults on a short-term basis. Magnesium hydroxide is in a class of medications called saline laxatives. It works by causing water to be retained with the stool. This increases the number of bowel movements and softens the stool so it is easier to pass.
[Learn More]


Simethicone


Simethicone is used to treat the symptoms of gas such as uncomfortable or painful pressure, fullness, and bloating. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
[Learn More]


* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
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.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".