NDC 62011-0352 Health Mart Dual Action Complete

Famotidine, Calcium Carbonate, Magnesium Hydroxide

NDC Product Code 62011-0352

NDC CODE: 62011-0352

Proprietary Name: Health Mart Dual Action Complete 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: Famotidine, Calcium Carbonate, Magnesium Hydroxide 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.

Product Characteristics

Color(s):
PINK (C48328 - MOTTLED PINK AND WHITE)
Shape: ROUND (C48348)
Size(s):
17 MM
Imprint(s):
PLUS
Score: 1
Flavor(s):
BERRY (C73365)

NDC Code Structure

  • 62011 - Strategic Sourcing Services Llc
    • 62011-0352 - Health Mart Dual Action Complete

NDC 62011-0352-1

Package Description: 25 TABLET, CHEWABLE in 1 BOTTLE

NDC Product Information

Health Mart Dual Action Complete with NDC 62011-0352 is a a human over the counter drug product labeled by Strategic Sourcing Services Llc. The generic name of Health Mart Dual Action Complete is famotidine, calcium carbonate, magnesium hydroxide. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: Strategic Sourcing Services Llc

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 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.

Health Mart Dual Action Complete 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.

  • FAMOTIDINE 10 mg/1
  • CALCIUM CARBONATE 800 mg/1
  • MAGNESIUM HYDROXIDE 165 mg/1

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.

  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
  • D&C RED NO. 7 (UNII: ECW0LZ41X8)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
  • ISOMALT (UNII: S870P55O2W)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • MANNITOL (UNII: 3OWL53L36A)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SODIUM METABISULFITE (UNII: 4VON5FNS3C)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • TALC (UNII: 7SEV7J4R1U)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

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: Strategic Sourcing Services Llc
Labeler Code: 62011
FDA Application Number: ANDA204782 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: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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: 01-15-2020 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".

* Please review the disclaimer below.

Health Mart Dual Action Complete Product Label Images

Health Mart Dual Action Complete 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 Chewable Tablet)

Famotidine 10 mgCalcium carbonate 800 mgMagnesium hydroxide 165 mg

Purpose

Acid reducerAntacid

Use

Relieves heartburn associated with acid indigestion and sour stomach

Warnings

Allergy alert: Do not use if you are allergic to famotidine or other acid reducers

Do Not Use

  • •if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. •with other acid reducers

Ask A Doctor Before Use If You Have

  • •had heartburn over 3 months. This may be a sign of a more serious condition. •heartburn with lightheadedness, sweating, or dizziness •chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness •frequent chest pain •frequent wheezing, particularly with heartburn •unexplained weight loss •nausea or vomiting •stomach pain

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

  • •your heartburn continues or worsens •you need to take this product for more than 14 days

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 right away (1-800-222-1222).

Directions

  • •adults and children 12 years and over: •do not swallow tablet whole: chew completely •to relieve symptoms, chew 1 tablet before swallowing •do not use more than 2 chewable tablets in 24 hours •children under 12 years: ask a doctor

Other Information

  • •each tablet contains: calcium 335 mg; magnesium 80 mg •read the directions and warnings before use •read the bottle label. It contains important information. •store at 20-25°C (68-77°F) •protect from moisture

Inactive Ingredients

Anhydrous lactose, crospovidone, D&C red no. 7 calcium lake, ethylcellulose aqueous dispersion, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, glyceryl monostearate, hydroxypropyl cellulose, isomalt, magnesium stearate, maltodextrin, mannitol, mineral oil, natural and artificial berry type flavor, polysorbate 80, sodium metabisulfite, sucralose, talc, triethyl citrate

* Please review the disclaimer below.