NDC 55319-629 Regular Strength Antacid

Aluminum Hydroxide, Magnesium Hydroxide, Dimethicone

NDC Product Code 55319-629

NDC Code: 55319-629

Proprietary Name: Regular Strength Antacid 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, Dimethicone 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 Services Inc
    • 55319-629 - Regular Strength Antacid

NDC 55319-629-12

Package Description: 355 mL in 1 BOTTLE

NDC Product Information

Regular Strength Antacid with NDC 55319-629 is a a human over the counter drug product labeled by Family Dollar Services Inc. The generic name of Regular Strength Antacid is aluminum hydroxide, magnesium hydroxide, dimethicone. The product's dosage form is suspension and is administered via oral form.

Labeler Name: Family Dollar Services Inc

Dosage Form: Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.

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.

Regular Strength Antacid 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.

  • ALUMINUM HYDROXIDE 200 mg/5mL
  • MAGNESIUM HYDROXIDE 200 mg/5mL
  • DIMETHICONE 20 mg/5mL

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)
  • BUTYLPARABEN (UNII: 3QPI1U3FV8)
  • HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • SACCHARIN (UNII: FST467XS7D)
  • SORBITOL (UNII: 506T60A25R)

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 Services Inc
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: 06-01-2017 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: 12-31-2019 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

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.

Regular Strength Antacid Product Label Images

Regular Strength Antacid 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 Ingredients (In Each 5 Ml Teaspoonful)

Aluminum hydroxide 200 mg (equivalent to dried gel, USP)

Magnesium hydroxide 200 mg

Simethicone 20mg

Purposes

Antacid

Antigas

Uses

  • Relievesheartburnsour stomachacid indigestionthe symptoms referred to as gasupset stomach due to these symptoms

Warnings

  • Ask a doctor before use if you have kidney diseasea magnesium-restricted dietAsk a doctor or pharmacist before use if you are 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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

  • Shake well before useadults and children 12 years and older: take 2 to 4 teaspoonfuls between meals, at bedtime, or as directed by a doctordo not take more than 24 teaspoonfuls in 24 hours or use the maximum dosage for more than 2 weekschildren under 12 years: ask a doctor

Other Information

  • Each 5 mL teaspoonful contains: magnesium 85 mg, sodium 3 mg
  • Do not freezestore at room temperature tightly closed

Inactive Ingredients

Benzyl alcohol, butylparaben, flavor (contains alcohol), hydroxyethylcellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

Package Label

FAMILY WELLNESSCOMPARE TO THE ACTIVE INGREDIENTS

OF MYLANTA® REGULAR STRENGTH*

REGULAR STRENGTH
Antacid

Alumina, Magnesia, and Simethicone
Oral SuspensionFor Soothing Relief of:

• Heartburn

• Acid Indigestion

• Sour Stomach

ORIGINAL FLAVOR
Alcohol: 0.15%

12 FL OZ (355 mL)
OTC NETWORK

* Please review the disclaimer below.

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