NDC 70000-0476 Leader Antacid

Aluminum Hydroxide, Magnesium Hydroxide, Simethicone

NDC Product Code 70000-0476

NDC Code: 70000-0476

Proprietary Name: Leader Antacid 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, Magnesium Hydroxide, Simethicone 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.


Code Structure
  • 70000 - Cardinal Health
    • 70000-0476 - Leader Antacid

NDC 70000-0476-1

Package Description: 355 mL in 1 BOTTLE

NDC Product Information

Leader Antacid with NDC 70000-0476 is a a human over the counter drug product labeled by Cardinal Health. The generic name of Leader Antacid is aluminum hydroxide, magnesium hydroxide, simethicone. The product's dosage form is suspension and is administered via oral form.

Labeler Name: Cardinal Health

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

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.


Leader Antacid 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 400 mg/10mL
  • MAGNESIUM HYDROXIDE 400 mg/10mL
  • DIMETHICONE 40 mg/10mL

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.

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

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: 03-05-2019 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.

Leader Antacid Product Label Images

Leader 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 10 Ml)

Aluminum hydroxide (equiv. to dried gel, USP) 400 mgMagnesium hydroxide 400 mgSimethicone 40 mg

Purposes

AntacidAntigas

Uses

  • Relieves •heartburn •acid indigestion •sour stomach •upset stomach due to 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 exceed 120 mL in a 24-hour period, or use the maximum dosage for more than 2 weeks, unless directed by a doctor

Keep Out Of Reach Of Children.

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

Directions

  • •shake well before use •measure with dosing cup provided •adults and children 12 years and over: 10 mL – 20 mL between meals, at bedtime or as directed by a doctor •do not take more than 120 mL in any 24 hour period •do not use the maximum dosage for more than 2 weeks •children under 12 years: ask a doctor •mL = milliliter

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), do not freeze

Inactive Ingredients

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

* Please review the disclaimer below.

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