NDC 17856-0832 Sunmark

Mineral

NDC Product Code 17856-0832

NDC Code: 17856-0832

Proprietary Name: Sunmark 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: Mineral 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

  • 17856 - Atlantic Biologicals Corp.
    • 17856-0832 - Sunmark

NDC 17856-0832-1

Package Description: 50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE > 30 mL in 1 CUP, UNIT-DOSE

NDC Product Information

Sunmark with NDC 17856-0832 is a a human over the counter drug product labeled by Atlantic Biologicals Corp.. The generic name of Sunmark is mineral. The product's dosage form is oil and is administered via oral form.

Labeler Name: Atlantic Biologicals Corp.

Dosage Form: Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.

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.

Sunmark 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.

  • MINERAL OIL 999 mg/mL

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.

  • TOCOPHEROL (UNII: R0ZB2556P8)

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: Atlantic Biologicals Corp.
Labeler Code: 17856
FDA Application Number: part334 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 04-10-2019 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.

Sunmark Product Label Images

Sunmark 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 Ingredient

Mineral oil 99.9%

Purpose

Lubricant laxative

Use

For relief of occasional constipation (irregularity).  Generally produces bowel movement in 6 to 8 hours.

Do Not Use

  • If you have difficulty swallowingin children under 6 years of ageif you are pregnantfor a period longer than weekif you are bedridden or aged

Ask A Doctor Before Use If You Have

  • Abdominal pain, nausea, or vomitingnoticed a sudden change in bowel habits that persists over a period of 2 weeks

Ask A Doctor Or Pharmacist Before Use If You Are

  • Presently taking a stool softener laxativetaking any other drug.  Take this product 2 or more hours before or after other drugs.  Laxatives may affect how other drugs work.

When Using This Product

Do not take with meals.  Take only at bedtime.

Stop Use And Ask A Doctor

If you have rectal bleeding or failure to have a bowel movement after use.  These could be signs of a serious condition.

If 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

Directions

  • Do not take with mealstake only at bedtimemay be taken as a single daily dose or in divided dosesadults and children 12 years of age and over - 1 to 3 Tablespoons (15 - 45 mL) maximum 3 Tablespoons (45 mL) in 24 hourschildren 6 to under 12 years of age - 1 to 3 teaspoons (5 - 15 mL) maximum 3 teaspoons (15 mL) in 24 hourschildren under 6 years of age - do not use, consult a doctor

Other Information

Keep tightly closed.  Protect from sunlight.

Inactive Ingredients

Mixed tocopherols (added as a stabilizer)

Adverse Reaction Section

DISTRIBUTED BY:ALTANTIC BIOLOGICALS CORP.20101 NE 16TH PLACEMIAMI, FL 33179

* Please review the disclaimer below.

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