NDC 70000-0442 Stool Softener And Stimulant Laxative

Docusate Sodium And Sennosides

NDC Product Code 70000-0442

NDC Code: 70000-0442

Proprietary Name: Stool Softener And Stimulant Laxative 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 And 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.


Product Characteristics
Color(s):
RED (C48326 - OPAQUE)
Shape: CAPSULE (C48336)
Size(s):
12 MM
Imprint(s):
584
Score: 1

Code Structure
  • 70000 - Leader
    • 70000-0442 - Stool Softener And Stimulant Laxative

NDC 70000-0442-1

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

NDC Product Information

Stool Softener And Stimulant Laxative with NDC 70000-0442 is a a human over the counter drug product labeled by Leader. The generic name of Stool Softener And Stimulant Laxative is docusate sodium and sennosides. 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 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.


Stool Softener And Stimulant Laxative 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.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GELATIN (UNII: 2G86QN327L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • POVIDONE K30 (UNII: U725QWY32X)
  • WATER (UNII: 059QF0KO0R)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • SORBITOL (UNII: 506T60A25R)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • 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: Leader
Labeler Code: 70000
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: 01-30-2019 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.

Stool Softener And Stimulant Laxative Product Label Images

Stool Softener And 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

Other

DRUG FACTS

*This product is not manufactured or distributed by Purdue


Products L.P., owner of the registered trademark Colace® 2-IN-1.


© 2019 Cardinal Health. All Rights Reserved. CARDINAL HEALTH,


the Cardinal Health LOGO, LEADER, and the Leader LOGO are


trademarks or registered trademarks of Cardinal Health. All other


marks are the property of their respective owners.


DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017


www.myleader.com 1-800-200-6313


Made in India


All LEADER™ Brand Products Have A


Return to place of purchase if not satisfied.


100% Money Back Guarantee


TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY


SEAL UNDER CAP IS BROKEN OR MISSING.


KEEP OUTER CARTON FOR COMPLETE


WARNINGS AND PRODUCT INFORMATION

Otc - Purpose

PurposeStool softener


Stimulant Laxative

Otc - Active Ingredient

Active ingredients(in each softgel) Docusate sodium 50 mg


Sennosides 8.6 mg

Uses

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

Warnings

Warnings

Otc - Do Not Use

  • Do not uselaxative products for longer than 1 week unless told to do so by a doctorif you are presently taking mineral oil, unless told to do so by a doctor

Otc - Ask Doctor

  • Ask a doctor before use if you havestomach painnauseavomitingnoticed 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 (1800-222-1222) 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 of age or over take 2-4 softgels daily children 6 to under 12 years of age       take 1-2 softgels daily children 2 to under 6 years of age    take upto 1 softgel daily children under 2 ask a doctor

Other Information

  • Each softgel contains: calcium 2 mg and sodium 3 mg
  • Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)Keep tightly closed

Inactive Ingredients

Aerosil, beeswax, FD&C Red No.33, FD&C Red No.40, gelatin, glycerin, light liquid paraffin, povidone (PVP K-30), purified water, sodium carboxymethylcellulose, sorbitol solution, soya lecithin, titanium dioxide

* Please review the disclaimer below.

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