NDC 70000-0403 Sennosides, Docusate Sodium

Sennosides, Docusate Sodium

NDC Product Code 70000-0403

NDC Code: 70000-0403

Proprietary Name: Sennosides, Docusate Sodium Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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

Code Structure
  • 70000 - Cardinal Health
    • 70000-0403 - Sennosides, Docusate Sodium

NDC 70000-0403-1

Package Description: 100 TABLET, FILM COATED in 1 BOTTLE

NDC Product Information

Sennosides, Docusate Sodium with NDC 70000-0403 is a a human over the counter drug product labeled by Cardinal Health. 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: Cardinal Health

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 Additional informationCallout TooltipWhat 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)

Additional informationCallout TooltipWhat 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)

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

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Cardinal Health
Labeler Code: 70000
FDA Application Number: part334 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 01-10-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Information for Patients

Senna

Senna is pronounced as (sen' a)

Why is senna medication prescribed?
Senna is used on a short-term basis to treat constipation. It also is used to empty the bowels before surgery and certain medical procedures. Senna is in a class of medic...
[Read More]
Stool Softeners

Stool Softeners is
Why is stool softeners medication prescribed?
Stool softeners are used on a short-term basis to relieve constipation by people who should avoid straining during bowel movements because of heart conditions, hemorrhoid...
[Read More]

* Please review the disclaimer below.

Sennosides, Docusate Sodium Product Label Images

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

  • Relieves 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 doctorif you are now taking mineral oil, unless directed by a doctor

Otc - Ask Doctor

  • Ask a doctor before use if you havestomach pain nausea 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.

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 (1-800-222-1222) 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 children12 years and oldertake 2-4tablets dailychildren 6 to under12 years of agetake 1-2tablets dailychildren 2 to under 6years of agetake up to 1tablet dailychildren under 2 yearsask 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, triacetin

Other

Do not use if product appears to be tampered with or seal is broken.†This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace®2-IN-1.DISTRIBUTED BY CARDINAL HEALTHDUBLIN, OHIO 43017www.myleader.com 1-800-200-6313100% Money Back GuaranteeReturn to place of purchase if not satisfied.© 2018 Cardinal Health. All Rights Reserved. CARDINAL HEALTH,the Cardinal Health LOGO, LEADER, and the Leader LOGO aretrademarks or registered trademarks of Cardinal Health.

* Please review the disclaimer below.

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