NDC 70000-0234 Extra Strength Antacid Original Flavor

Aluminum Hydroxide And Magnesium Carbonate

NDC Product Code 70000-0234

NDC Code: 70000-0234

Proprietary Name: Extra Strength Antacid Original Flavor Additional informationCallout TooltipWhat 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 And Magnesium Carbonate Additional informationCallout TooltipWhat 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.


Product Characteristics
Color(s):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
17 MM
Imprint(s):
RP105
Score: 1
Flavor(s):
BUTTERSCOTCH (C73372 - ORIGINAL)

Code Structure
  • 70000 - Cardinal Health
    • 70000-0234 - Extra Strength Antacid

NDC 70000-0234-1

Package Description: 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC

NDC Product Information

Extra Strength Antacid Original Flavor with NDC 70000-0234 is a a human over the counter drug product labeled by Cardinal Health. The generic name of Extra Strength Antacid Original Flavor is aluminum hydroxide and magnesium carbonate. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: Cardinal Health

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.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Extra Strength Antacid Original Flavor Active Ingredient(s)

Additional informationCallout TooltipWhat 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 160 mg/1
  • MAGNESIUM CARBONATE 105 mg/1

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • ALGINIC ACID (UNII: 8C3Z4148WZ)
  • CALCIUM STEARATE (UNII: 776XM7047L)
  • CORN SYRUP (UNII: 9G5L16BK6N)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • SUCROSE (UNII: C151H8M554)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Cardinal Health
Labeler Code: 70000
FDA Application Number: part331 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 03-04-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Extra Strength Antacid Original Flavor Product Label Images

Extra Strength Antacid Original Flavor 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 Tablet)

Aluminum hydroxide 160 mgMagnesium carbonate 105 mg

Purpose

AntacidAntacid

Uses

  • Relieves •acid indigestion •heartburn •sour stomach •upset stomach associated with these symptoms

Warnings

Consuming this product can expose you to chemicals including lead, which is known to the State of California to cause cancer. For more information, go to www.P65Warningd.ca.gov

Ask A Doctor Or Pharmacist Before Use If You Are

  • •taking a prescription drug. Antacids may interact with certain prescription drugs •If you are on a sodium-restricted diet

When Using This Product

  • •do not take more than 16 tablets in 24 hours •do not use the maximum dosage for more than 2 weeks

Keep Out Of Reach Of Children.

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

Directions

  • •chew 2 to 4 tablets four times a day or as directed by a doctor •take after meals and at bedtime or as needed •for best results follow by a half glass of water or other liquid •DO NOT SWALLOW WHOLE

Other Information

  • •Each tablet contains: magnesium 31 mg, sodium 19 mg •Store at room temperature.

Inactive Ingredients

Alginic acid, calcium stearate, compressible sugar, flavor, sodium bicarbonate, starch (corn), sucrose.

* Please review the disclaimer below.

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