Antacid And Antigas Liquid
NDC 83324-343
3 active ingredients · Liquid (oral)
Product Information
Antacid And Antigas (calcium carbonate, magnesium hydroxide, simethicone) is a OTC MONOGRAPH DRUG-approved product labeled by Chain Drug Marketing Association, Inc.. This medication is typically used as a blood coagulation factor [epc]. It is supplied as a liquid for oral administration. This product entry covers the primary NDC 83324-343 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
83324-343
Proprietary Name:
Antacid And Antigas
Non-Proprietary Name: [1]
Calcium Carbonate, Magnesium Hydroxide, Simethicone
Substance Name: [2]
Calcium Carbonate; Dimethicone; Magnesium Hydroxide
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Liquid
- A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
83324
Product Label ID:
FDA Application Number: [6]
M001
Marketing Category: [8]
OTC MONOGRAPH DRUG
Marketing Timeline
Start Marketing Date: [9]
10-01-2026
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 83324-343?
The NDC code 83324-343 is assigned by the FDA to the product Antacid And Antigas. It is commonly known by its generic name, calcium carbonate, magnesium hydroxide, simethicone. This pharmaceutical product is labeled by Chain Drug Marketing Association, Inc. and is currently categorized as listed product. The medication is a liquid administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 83324-343-12. 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?
Shake well before useadults and children 12 years of age and older: take 10 mL to 20 mL (1 to 2 doses) between meals as needed, at bedtime,or as directed by a doctordo not take more than 60 mL (6 doses) in any 24-hour period or use the maximum dosage for more than 2 weekschildren under 12 years of age: ask a doctormL = milliliter
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.
- CALCIUM CARBONATE 800 mg/10mL - Carbonic acid calcium salt (CaCO3). An odorless, tasteless powder or crystal that occurs in nature. It is used therapeutically as a phosphate buffer in hemodialysis patients and as a calcium supplement.
- DIMETHICONE 80 mg/10mL - a linear silicone; an ingredient of SIMETHICONE; lotion of dimeticone in a volatile silicone base has been used to treat LICE
- MAGNESIUM HYDROXIDE 270 mg/10mL - An inorganic compound that occurs in nature as the mineral brucite. It acts as an antacid with cathartic effects.
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.
- Blood Coagulation Factor - [EPC] (Established Pharmacologic Class)
- Calcium - [CS]
- Calculi Dissolution Agent - [EPC] (Established Pharmacologic Class)
- Cations, Divalent - [CS]
- Increased Coagulation Factor Activity - [PE] (Physiologic Effect)
- Increased Large Intestinal Motility - [PE] (Physiologic Effect)
- Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
- Inhibition Small Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
- Magnesium Ion Exchange Activity - [MoA] (Mechanism of Action)
- Osmotic Activity - [MoA] (Mechanism of Action)
- Osmotic Laxative - [EPC] (Established Pharmacologic Class)
- Phosphate Binder - [EPC] (Established Pharmacologic Class)
- Phosphate Chelating Activity - [MoA] (Mechanism of Action)
- Skin Barrier Activity - [PE] (Physiologic Effect)
- Stimulation Large Intestine Fluid/Electrolyte Secretion - [PE] (Physiologic Effect)
* 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".
