NDC 46122-669 Stool Softener Laxative

Docusate Sodium And Sennosides

NDC Product Code 46122-669

NDC CODE: 46122-669

Proprietary Name: Stool Softener Laxative 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 And Sennosides 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):
PSD21
Score: 1

NDC Code Structure

  • 46122 - Amerisourcebergen (good Neighbor Pharmacy) 46122

NDC 46122-669-78

Package Description: 100 TABLET in 1 BOTTLE, PLASTIC

NDC Product Information

Stool Softener Laxative with NDC 46122-669 is a a human over the counter drug product labeled by Amerisourcebergen (good Neighbor Pharmacy) 46122. The generic name of Stool Softener Laxative is docusate sodium and sennosides. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Amerisourcebergen (good Neighbor Pharmacy) 46122

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.

Stool Softener Laxative 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.

  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)

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: Amerisourcebergen (good Neighbor Pharmacy) 46122
Labeler Code: 46122
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: 03-26-2021 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: 12-31-2022 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.

Stool Softener Laxative 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 Tablet)

Docusate sodium 50 mgSennosides 8.6 mg

Purpose

Stool softenerStimulant laxative

Uses

  • Relieves occasional constipation (irregularity)
  • Generally produces bowel movement in 6 to12 hours

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

Ask A Doctor Before Use If You Have

  • Stomach painnauseavomitingnoticed a sudden change in bowel habits that lasts over a period of 2 weeks

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.

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.

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 daily children 6 to under 12 years of agetake 1-2 tablets daily children 2 to under 6 years of age take up to 1 tablet daily children under 2 ask a doctor

Other Information

  • Each tablet contains: calcium 30 mgeach tablet contains: sodium 6 mg VERY LOW SODIUM
  • Store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive Ingredients

Croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake,  hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silcon dioxide, talc, titanium dioxide

Product Label

GOOD DAY PHARMACY Stool Softener Laxative

* Please review the disclaimer below.