NDC 70518-1973 Almacone Double Strength

Aluminum Hydroxide, Magnesium Hydroxide, Dimethicone

NDC Product Code 70518-1973

NDC Code: 70518-1973

Proprietary Name: Almacone Double 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, 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

  • 70518 - Remedyrepack Inc.
    • 70518-1973 - Almacone Double Strength

NDC 70518-1973-0

Package Description: 10 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE > 20 mL in 1 CUP, UNIT-DOSE (70518-1973-1)

NDC Product Information

Almacone Double Strength with NDC 70518-1973 is a a human over the counter drug product labeled by Remedyrepack Inc.. The generic name of Almacone Double Strength is aluminum hydroxide, magnesium hydroxide, dimethicone. The product's dosage form is suspension and is administered via oral form.

Labeler Name: Remedyrepack 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.

Almacone Double 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.

  • ALUMINUM HYDROXIDE 400 mg/5mL
  • MAGNESIUM HYDROXIDE 400 mg/5mL
  • DIMETHICONE 40 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)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • 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: Remedyrepack Inc.
Labeler Code: 70518
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: 03-21-2019 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: 12-31-2020 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.

Almacone Double 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 Ingredients (In Each 5 Ml Teaspoonful)

Aluminum hydroxide 400 mg (equivalent to dried gel, USP)




Magnesium hydroxide 400 mg




Simethicone 40mg

Purposes

Antacid




Antigas

Uses

  • Relievesheartburnsour stomachacid indigestionsymptoms referred to as gas

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

  • Shake well before useadults and children 12 years of age and older: take 2 to 4 teaspoonfuls between meals, at bedtime, or as directed by a doctordo not take more than 12 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 165 mg, sodium 5 mg
  • Store at room temperatureprotect from freezingkeep tightly closed

Inactive Ingredients

Benzyl alcohol, butylparaben, carboxymethylcellulose sodium, flavor (contains alcohol), hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, sorbitol solution

* Please review the disclaimer below.

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