NDC 49348-019 Sunmark Antacid
Aluminum Hydroxide, Magnesium Hydroxide, Simethicone Suspension Oral

Product Information

Sunmark Antacid is a human over the counter drug product labeled by Strategic Sourcing Services Llc. The generic name of Sunmark Antacid is aluminum hydroxide, magnesium hydroxide, simethicone. The product's dosage form is suspension and is administered via oral form.

Product Code49348-019
Proprietary Name 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.
Sunmark Antacid
Non-Proprietary Name 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.
Aluminum Hydroxide, Magnesium Hydroxide, Simethicone
Product Type 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.
Human Otc Drug
Dosage FormSuspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
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.
Strategic Sourcing Services Llc
Labeler Code49348
FDA Application Number 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.
part332
Marketing Category 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.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
09-13-2003
Listing Expiration Date 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.
12-31-2022
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Sunmark Antacid?


Product Characteristics

Color(s)WHITE (C48325 - OPAQUE)
Flavor(s)MINT (C73404)

Product Packages

NDC 49348-019-39

Package Description: 355 mL in 1 BOTTLE

Price per Unit: $0.00798 per ML

Product Details

What are Sunmark Antacid Active Ingredients?

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.

NDC to RxNorm Crosswalk

What is RxNorm? 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: 307746 - aluminum hydroxide 200 MG / magnesium hydroxide 200 MG / simethicone 20 MG in 5 mL Oral Suspension
  • RxCUI: 307746 - aluminum hydroxide 40 MG/ML / magnesium hydroxide 40 MG/ML / simethicone 4 MG/ML Oral Suspension
  • RxCUI: 307746 - aluminum hydroxide 1200 MG / milk of magnesia 1200 MG / dimethicone 120 MG per 30 ML Oral Suspension
  • RxCUI: 307746 - aluminum hydroxide 200 MG / milk of magnesia 200 MG / dimethicone 20 MG per 5 ML Oral Suspension
  • RxCUI: 307746 - aluminum hydroxide 400 MG / milk of magnesia 400 MG / dimethicone 40 MG per 10 ML Oral Suspension

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.
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • BUTYLPARABEN (UNII: 3QPI1U3FV8)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SORBITOL (UNII: 506T60A25R)
  • PEPPERMINT OIL (UNII: AV092KU4JH)

Pharmacologic Class(es)

* Please review the disclaimer below.

Patient Education

Aluminum Hydroxide and Magnesium Hydroxide

Aluminum Hydroxide and Magnesium Hydroxide is pronounced as (a loo' mi num) (hye drox' ide) (mag nee' zhum) (hye drox' ide)

Why is aluminum hydroxide and magnesium hydroxide medication prescribed?
Aluminum Hydroxide, Magnesium Hydroxide are antacids used together to relieve heartburn, acid indigestion, and upset stomach. They may be used to treat these symptoms in ...
[Read More]
Simethicone

Simethicone is pronounced as (sye meth' i kone)
Why is simethicone medication prescribed?
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;...
[Read More]

* Please review the disclaimer below.

Sunmark Antacid Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredients (In Each 10 Ml)



Aluminum hydroxide (equiv. to dried gel, USP) 400 mg

Magnesium hydroxide 400 mg

Simethicone 40 mg


Purpose



Antacid

Antigas


Uses



for the relief of

  • •acid indigestion
  • •heartburn
  • •sour stomach
  • •upset stomach associated with these symptoms
  • •pressure and bloating commonly referred to as gas

Ask A Doctor Before Use If You Have



  • •kidney disease
  • •a magnesium-restricted diet

Ask A Doctor Or Pharmacist Before Use If You Are



presently taking a prescription drug. Antacids may interact with certain prescription drugs.


When Using This Product



do not take more than 80 mL in a 24-hour period, or use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician


Directions



  • •shake well before using
  • •only use the dose cup provided
  • •adults and children 12 years and older: take 10 mL to 20 mL four times a day or as directed by a physician
  • •do not take more than 80 mL in 24 hours or use the maximum dosage for more than 2 weeks
  • •children under 12 years: consult a physician

Other Information



  • •each 10 mL contains: magnesium 175 mg
  • •does not meet USP requirements for preservative effectiveness
  • •store at 20-25°C (68-77°F)
  • •protect from freezing

Inactive Ingredients



butylparaben, flavor, hypromellose, microcrystalline cellulose and carboxymethylcellulose sodium, peppermint oil, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol, sorbitol solution


Questions Or Comments?



1-800-719-9260


Principal Display Panel



COMPARE TO MAALOX® ADVANCED ACTIVE INGREDIENTS

antacid

Regular Strength

Advanced

Antacid / Antigas

Fast relief heartburn & acid indigestion Pressure & Bloating

MINT FLAVOR

GLUTEN FREE

12 FL OZ (355 mL)


* Please review the disclaimer below.