NDC 55319-528 Antacid Antigas Maximum Strength

Aluminum Hydroxide, Magnesium Hydroxide, Simethicone

NDC Product Code 55319-528

NDC CODE: 55319-528

Proprietary Name: Antacid Antigas Maximum Strength 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: Aluminum Hydroxide, Magnesium Hydroxide, Simethicone 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.

NDC Code Structure

  • 55319 - Family Dollar (family Wellness)

NDC 55319-528-12

Package Description: 355 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Antacid Antigas Maximum Strength with NDC 55319-528 is a a human over the counter drug product labeled by Family Dollar (family Wellness). The generic name of Antacid Antigas Maximum Strength is aluminum hydroxide, magnesium hydroxide, simethicone. The product's dosage form is liquid and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 237870.

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.

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.

Antacid Antigas Maximum Strength 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.

  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CARBONATE (UNII: 45P3261C7T)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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: Family Dollar (family Wellness)
Labeler Code: 55319
FDA Application Number: part331 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: 06-30-2018 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: 12-31-2021 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".

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Information for Patients

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.

Antacid Antigas Maximum Strength 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

Active Ingredient (In Each 10 Ml)

Aluminum hydroxide (equiv. to dried gel USP) 800 mgMagnesium Hydroxide 800 mgSimethicone 80 mg

Purpose

AntacidAntacidAntigas

Uses

  • For the relief of
  • Acid indigestionheartburnsour stomachupset stomach associated with these symptomspressure and bloating commonly referred to as gasoverindulgence in food and drink

Do Not Take

More than 60 mL in a 24-hour period or use the maximum dosage for more than 2 weeks except under the advice and supervision of a physican

Ask A Doctor Before Use If You Have

  • Kidney diseasea 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.

Stop Use And Ask A Doctor If

Symptoms last more than 2 weeks.

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • Shake well before usingmL = milliliterdo not take more than 60 mL in 24 hours or use the maximum dosage for more than 2 weeksmeasure only with dosing cup provided. Do not use any other dosing devicekeep dosing cup with productadults and children12 years and older: take 10-20 mL as needed, between or after meals, at bedtime, or as directed by a doctorchildren under 12 years of age: do not use

Other Information

  • Each 10 mL contains: magnesium 335 mg, sodium 10 mgstore between  20-25°C (68-77°F).Avoid freezing

Inactive Ingredients

Benzyl alcohol, carboxymethylcellulose sodium, flavor, glycerin, microcrystalline cellulose, purified water, sodium carbonate, sorbitol, sucralose, xanthan gum

Product Label

FAMILY WELLNESS Maximum Strength Antacid & Antigas Relief

* Please review the disclaimer below.