NDC 0904-6723 Sennosides, Docusate Sodium

Sennosides, Docusate Sodium

NDC Product Code 0904-6723

NDC Code: 0904-6723

Proprietary Name: Sennosides, Docusate Sodium 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: Sennosides, 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):
RED (C48326)
Shape: ROUND (C48348)
Size(s):
10 MM
Imprint(s):
CPC;490
Score: 1

NDC Code Structure

NDC 0904-6723-60

Package Description: 100 TABLET, FILM COATED in 1 BOTTLE

NDC 0904-6723-61

Package Description: 10 BLISTER PACK in 1 BOX > 10 TABLET, FILM COATED in 1 BLISTER PACK

NDC Product Information

Sennosides, Docusate Sodium with NDC 0904-6723 is a a human over the counter drug product labeled by Major Pharmaceuticals. The generic name of Sennosides, Docusate Sodium is sennosides, docusate sodium. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Major Pharmaceuticals

Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

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.

Sennosides, Docusate Sodium 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 50 mg/1
  • SENNOSIDES 8.6 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.

  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • CROSCARMELLOSE (UNII: 029TFK992N)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • FOOD YELLOW 3 FREE ACID (UNII: G2B7JWK1GG)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • TALC (UNII: 7SEV7J4R1U)
  • TRIACETIN (UNII: XHX3C3X673)
  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)

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: 01-31-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 04-30-2022 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

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.

Sennosides, Docusate Sodium 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

Drug Facts

Active ingredients (in each tablet)Docusate sodium 50 mgSennosides 8.6 mg

Otc - Purpose

PurposesStool softenerStimulant laxative

Uses 

  • For overnight relief from occasional constipation (irregularity)generally produces bowel movement in 6 to 12 hours

Otc - Do Not Use

  • Do not use 
  • Laxative products for longer than 1 week unless directed by a doctor if you are now taking mineral oil, unless directed by a doctor

Otc - Ask Doctor

  • Ask a doctor before use if you havestomach painnausea vomitingnoticed a sudden change in bowel habits that lasts over a period of 2 weeks

Otc - Stop Use

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdosage

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.adults and children 12 years and oldertake 2-4 tablets dailychildren 6 to under 12 years of agetake 1-2 tablets dailychildren 2 to under 6 years of agetake up to 1 tablet daily children under 2ask a doctor

Other Information

  • Each tablet contains: calcium 11 mg
  • Each tablet contains: sodium 4 mg
  • Store at 25°C (77°F); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive Ingredient

Croscarmellose sodium, dicalcium phosphate, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #6 lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide and triacetin.

Other

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.Distributed by:
MAJOR® PHARMACEUTICALS17177 N Laurel Park Drive, Suite 233Livonia, MI 48152 USA†This product is not manufactured or distributed by Purdue Products L.P., distributor of Colace®2-IN-1.

* Please review the disclaimer below.