NDC 0904-6750 Dok

Docusate Sodium

NDC Product Code 0904-6750

NDC Code: 0904-6750

Proprietary Name: Dok 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: Docusate Sodium 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):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
11 MM
Imprint(s):
GC422
Score: 1

NDC Code Structure

NDC 0904-6750-60

Package Description: 100 TABLET in 1 BOTTLE

NDC Product Information

Dok with NDC 0904-6750 is a a human over the counter drug product labeled by Major Pharmaceuticals. The generic name of Dok is docusate sodium. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Major Pharmaceuticals

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.

Dok 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.

  • DOCUSATE SODIUM 100 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.

  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • TALC (UNII: 7SEV7J4R1U)

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: Major Pharmaceuticals
Labeler Code: 0904
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: 06-01-2018 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.

Dok Product Label Images

Dok 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

Docusate Sodium 100 mg

Purpose

Stool Softener Laxative

Uses

  • Relieves occasional constipation (irregularity)generally produces bowel movement in 12 to 72 hours

Warnings

  • Ask a doctor before use if youhave stomach pain, nausea or vomitinghave a sudden change in bowel habits that persists over a period of 2 weeksare presently taking mineral oilStop use and ask a doctor if you need to use a laxative longer than 1 weekyou have rectal bleeding or fail to have a bowel movement. These could be signs of a serious condition.If pregnant or breast-feeding, ask a health professional before use.

Keep Out Of Reach Of Children

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children 12 years and older:take 1 tablet as needed, not to exceed 3 tablets daily, or as directed by a doctorchildren under 12: consult a doctortablets may be swallowed whole or crushed and mixed with food

Other Information

  • Each tablet contains: calcium 50 mg, sodium 8 mg
  • Package not child resistantstore at room temperature 15°C-30°C (59°F-86°F)Tamper Evident: Do not use if imprinted seal under cap is missing or broken

Inactive Ingredients

Cellulose, croscarmellose sodium, dicalcium phosphate, magnesium stearate, silica, stearic acid, talc

* Please review the disclaimer below.