NDC 49035-828 Stool Softener Plus Stimulant Laxative

Docusate Sodium, Sennosides

NDC Product Code 49035-828

NDC Code: 49035-828

Proprietary Name: Stool Softener Plus Stimulant Laxative 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: Docusate Sodium, Sennosides 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):
TCL097;PSD21;S44
Score: 1

Code Structure
  • 49035 - Equate (wal-mart Stores, Inc.)
    • 49035-828 - Stool Softener Plus Stimulant Laxative

NDC 49035-828-12

Package Description: 120 TABLET in 1 BOTTLE, PLASTIC

NDC 49035-828-24

Package Description: 240 TABLET in 1 BOTTLE, PLASTIC

NDC Product Information

Stool Softener Plus Stimulant Laxative with NDC 49035-828 is a a human over the counter drug product labeled by Equate (wal-mart Stores, Inc.). The generic name of Stool Softener Plus Stimulant Laxative is docusate sodium, sennosides. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Equate (wal-mart Stores, Inc.)

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

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.


Stool Softener Plus Stimulant Laxative 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.

  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)

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: Equate (wal-mart Stores, Inc.)
Labeler Code: 49035
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: 02-28-2019 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.

Stool Softener Plus Stimulant Laxative Product Label Images

Stool Softener Plus Stimulant 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

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

Do Not Use

  • Laxative products for longer than 1 week unless told to do so by a doctorif you are now taking mineral oil, unless directed by a doctor

Ask A Doctor Before Use If You Have

  • Stomach pain
  • Nausea
  • Vomiting
  • Noticed a sudden change in bowel habits that lasts over 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 dailychildren 6 to under 12 years of agetake 1-2 tablets dailychildren 2 to under 6 years of agetake up to 1 tablet dailychildren under 2ask 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

Carnauba wax*, 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, silicon dioxide, sodium benzoate*, stearic acid, talc*, titanium dioxide*contains one or more of these ingredients

Product Label

EQUATE Stool Softener

* Please review the disclaimer below.

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