NDC 65437-035 Senna Leaf And Docusate Sodium

NDC Product Code 65437-035

NDC CODE: 65437-035

Proprietary Name: Senna Leaf And Docusate Sodium 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.

Product Characteristics

Color(s):
ORANGE (C48331)
Shape: ROUND (C48348)
Size(s):
9 MM
Score: 1

NDC Code Structure

NDC 65437-035-50

Package Description: 1 BAG in 1 DRUM > 50000 TABLET, FILM COATED in 1 BAG

NDC 65437-035-70

Package Description: 1 BAG in 1 DRUM > 75000 TABLET, FILM COATED in 1 BAG

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Senna Leaf And Docusate Sodium with NDC 65437-035 is a product labeled by Himprit Pharmachem Pvt Ltd. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 998740.

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.

  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • WATER (UNII: 059QF0KO0R)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • HYPROMELLOSE (UNII: 3NXW29V3WO)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Himprit Pharmachem Pvt Ltd
Labeler Code: 65437
Start Marketing Date: 04-01-2010 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: 12-31-2018 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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.

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 Leaf And Docusate Sodium Product Label Images

Senna Leaf And Docusate Sodium 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 (in each tablet)PurposeDocusate sodium 50 mgStool softenerSennosides 8.6 mgLaxative

Uses

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

Directions

  • Take preferably at bedtime or as directed by a doctoragestarting dosagemaximum dosageadults and children 12 years of age or older2 tablets once a day4 tablets twice a daychildren 6 to under 12 years1 tablet once a day2 tablets twice a daychildren 2 to under 6 years1/2 tablet once a day1 tablet twice a daychildren under 2 yearsask a doctorask a doctor

Inactive Ingredients

Carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, PEG 8000, sodium benzoate, stearic acid, tartaric acid, titanium dioxide

* Please review the disclaimer below.