NDC 69517-131 Senna-s

Senna And Docusate Sodium Tablets, 8.6 Mg And 50 Mg

NDC Product Code 69517-131

NDC CODE: 69517-131

Proprietary Name: Senna-s 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: Senna And Docusate Sodium Tablets, 8.6 Mg And 50 Mg 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):
ORANGE (C48331)
Shape: ROUND (C48348)
Size(s):
10 MM
Imprint(s):
S35
Score: 1

NDC Code Structure

NDC 69517-131-02

Package Description: 2 POUCH in 1 POUCH > 2 TABLET, COATED in 1 POUCH

NDC 69517-131-10

Package Description: 1000 BOTTLE in 1 BOTTLE > 500 BOTTLE in 1 BOTTLE (69517-131-05) > 24 CARTON in 1 BOTTLE (69517-131-24) > 1 TABLET, COATED in 1 CARTON

NDC 69517-131-25

Package Description: 25 POUCH in 1 BOX > 2 TABLET, COATED in 1 POUCH

NDC 69517-131-50

Package Description: 50 POUCH in 1 BOX > 2 TABLET, COATED in 1 POUCH

NDC Product Information

Senna-s with NDC 69517-131 is a a human over the counter drug product labeled by Healthlife Of Usa Llc. The generic name of Senna-s is senna and docusate sodium tablets, 8.6 mg and 50 mg. The product's dosage form is tablet, coated and is administered via oral form.

Labeler Name: Healthlife Of Usa Llc

Dosage Form: Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.

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 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.

  • SENNOSIDES 8.6 mg/1
  • DOCUSATE SODIUM 50 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)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: Healthlife Of Usa Llc
Labeler Code: 69517
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: 03-07-2016 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: 12-31-2021 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".

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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]

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Senna-s Product Label Images

Senna-s 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 tablet)          PurposeDocusate sodium 50 mg.......................................Stool softnerSennosides 8.6 mg................................................Laxative

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 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.

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 right away.

Directions

  • Take preferably at bedtime or as directed by a doctoradults and children 12 years of age or older - starting dosage: 2 tablets once a day, maximum dosage: 4 tablets twice a daychildren 6 to under 12 years - starting dosage: 1 tablet once a day, maximum dosage: 2 tablets twice a daychildren 2 to under 6 years - starting dosage: 1/2 tablet once a day, maximum dosage: 1 tablet twice a daychildren under 2 years - starting dosage: ask a doctor, maximum dosage: ask a doctor

Other Information

  • Each tablet contains: calcium 21 mgeach tablet contains: sodium 3 mg VERY LOW SODIUMstore at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)read all product information before usingTAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive Ingredients

Croscarmellose sodium, colloidal silicon dioxide, dicalcium phosphate, D&C Yellow # 10, FD&C Yellow # 6, hypromellose, microcrystalline cellulose, magnesium stearate, maltodextrin, polyethylene glycol, stearic acid, titanium dioxide

* Please review the disclaimer below.