NDC 72476-883 Senna S Orange

Docusate Sodium Sennosides

NDC Product Code 72476-883

NDC CODE: 72476-883

Proprietary Name: Senna S Orange 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 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat occasional constipation. Some medications and conditions can make constipation more likely. Stool softeners such as docusate are often the first method used for preventing and treating this type of constipation. Docusate is often used when straining to have a bowel movement should be avoided (e.g., after a heart attack or surgery). Docusate is a stool softener. It works by increasing the amount of water the stool absorbs in the gut, making the stool softer and easier to pass.
  • Sennosides are used to treat constipation. They may also be used to clean out the intestines before a bowel examination/surgery. Sennosides are known as stimulant laxatives. They work by keeping water in the intestines, which causes movement of the intestines.

Product Characteristics

Color(s):
ORANGE (C48331)
Shape: ROUND (C48348)
Size(s):
10 MM
Imprint(s):
PSD22
Score: 1

NDC Code Structure

  • 72476 - Care One (retail Business Services, Llc.)

NDC 72476-883-60

Package Description: 1 BOTTLE, PLASTIC in 1 BOX > 60 TABLET in 1 BOTTLE, PLASTIC

NDC Product Information

Senna S Orange with NDC 72476-883 is a a human over the counter drug product labeled by Care One (retail Business Services, Llc.). The generic name of Senna S Orange is docusate sodium sennosides. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Care One (retail Business Services, Llc.)

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.

Senna S Orange 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 YELLOW NO. 6 (UNII: H77VEI93A8)
  • 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)

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.
  • 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: Care One (retail Business Services, Llc.)
Labeler Code: 72476
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: 09-30-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

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.

Senna S Orange Product Label Images

Senna S Orange 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 softenerLaxative

Uses

  • Relieves occasional constipation (irregularity)generally produces bowel movement in 6-12 hours

Do Not Use

  • If you are now taking mineral oil, unless directed by a doctorlaxative products for longer than 1 week unless directed by a doctor

Ask A Doctor Before Use If You Have

  • Stomach painnauseavomitingnoticed a sudden change in bowel habits that continues 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 preferably at bedtime or as directed by a doctor agestarting dosage maximum dosage adults and children 12 years of age or over2 tablets once a day4 tablets twice a day children 6 to under 12 years1 tablet once a day2 tablets twice a day children 2 to under 6 years1/2 tablet once a day 1 tablet twice a day children under 2 yearsask a doctor ask a doctor

Other Information

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

Inactive Ingredients

Croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate,  microcrystalline cellulose, polyethylene glycol, silicon dioxide, talc, titanium dioxide *contains one or more of these ingredients

Product Labeling

CAREONE Senna S Tablets

* Please review the disclaimer below.