NDC 70000-0445 Senna Plus

Docusate Sodium, 50 Mg Sennosides, 8.6 Mg

NDC Product Code 70000-0445

NDC Code: 70000-0445

Proprietary Name: Senna Plus 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, 50 Mg Sennosides, 8.6 Mg 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):
ORANGE (C48331 - OPAQUE)
Shape: CAPSULE (C48336)
Size(s):
6 MM
Imprint(s):
S62
Score: 1

Code Structure
  • 70000 - Leader
    • 70000-0445 - Senna Plus

NDC 70000-0445-1

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC

NDC Product Information

Senna Plus with NDC 70000-0445 is a a human over the counter drug product labeled by Leader. The generic name of Senna Plus is docusate sodium, 50 mg sennosides, 8.6 mg. The product's dosage form is capsule, gelatin coated and is administered via oral form.

Labeler Name: Leader

Dosage Form: Capsule, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.

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.


Senna Plus 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.

  • SENNOSIDES 8.6 1/1
  • DOCUSATE SODIUM 50 1/1

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.

  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • GELATIN (UNII: 2G86QN327L)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POVIDONE K30 (UNII: U725QWY32X)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SORBITOL (UNII: 506T60A25R)

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: Leader
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: 01-15-2019 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.

Senna Plus Product Label Images

Senna Plus 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

Other

Drug Facts

Otc - Purpose

Active ingredients                                      Purpose(in each softgel)Docusate sodium 50 mg..............................Stool softener


Sennosides 8.6 mg................................................Laxative

Uses

■ relieves occasional constipation (irregularity)


■ generally produces bowel movement in 6-12 hours

Otc - Ask 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

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. In case of overdose, get medical help or contact a Poison


Control Center (1-800-222-1222) right away.

Directions

Take preferably at bedtime or as directed by a doctor Age Starting dose Maximum Dosage adults and children 12 years of age or older 2 softgels once a day 4 softgels twice a day children 6 to under 12 years 1 softgel once a day 2 softgels twice a day children under 6 years of age ask a doctor ask a doctor

Other Information




each softgel contains: calcium 2 mg and sodium 3 mg


■ store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive Ingredients

FD&C yellow #6, gelatin, glycerin, polyethylene glycol-400, povidone (PVP K-30), propylene


glycol, purified water, sorbitol, titanium dioxide

Otc - Questions

Questions or comments?1-888-333-9792

* Please review the disclaimer below.

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