NDC 36800-994 Chocolated Laxative Regular Strength Sennosides Stimulant Laxative Topcare Health

Sennosides

NDC Product Code 36800-994

NDC CODE: 36800-994

Proprietary Name: Chocolated Laxative Regular Strength Sennosides Stimulant Laxative Topcare Health 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: 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.

  • 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):
BROWN (C48332 - BROWN)
Shape: RECTANGLE (C48347)
Size(s):
9 MM
Imprint(s):
CL
Score: 1

NDC Code Structure

  • 36800 - Topco Associates

NDC 36800-994-01

Package Description: 2 POUCH in 1 CARTON > 12 TABLET, CHEWABLE in 1 POUCH

NDC Product Information

Chocolated Laxative Regular Strength Sennosides Stimulant Laxative Topcare Health with NDC 36800-994 is a a human over the counter drug product labeled by Topco Associates. The generic name of Chocolated Laxative Regular Strength Sennosides Stimulant Laxative Topcare Health is sennosides. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: Topco Associates

Dosage Form: Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.

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.

Chocolated Laxative Regular Strength Sennosides Stimulant Laxative Topcare Health 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 15 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.

  • COCOA (UNII: D9108TZ9KG)
  • COTTON SEED (UNII: DI0ZRJ0MXN)
  • PALM KERNEL OIL (UNII: B0S90M0233)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • SUCROSE (UNII: C151H8M554)
  • VANILLA (UNII: Q74T35078H)
  • WHEY (UNII: 8617Z5FMF6)

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: Topco Associates
Labeler Code: 36800
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: 03-26-2021 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: 12-31-2022 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".

* Please review the disclaimer below.

Chocolated Laxative Regular Strength Sennosides Stimulant Laxative Topcare Health Product Label Images

Chocolated Laxative Regular Strength Sennosides Stimulant Laxative Topcare Health 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 Ingredient (In Each Piece Of 12 Piece Block)

Sennosides, USP, 15 mg

Purpose

Stimulant laxative

Uses

  • Relieves occasional constipation (irregularity)
  • Generally produces bowel movement in 6 to 12 hours

Otc - Do Not Use

Do not use laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor

Ask A Doctor Before Use If You Have

  • Noticed a sudden change in bowel habits that persists over a period of 2 weeks

Ask A Doctor Or Pharmacist Before Use If You

  • Are taking any other drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs.

When Using This Product

  • Do not use for a period longer than 1 week

Stop Use And Ask A Doctor If

  • Rectal bleeding or failure to have a bowel movement occur after use of a laxative. These may be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, 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

Adults and children 12 years of age and older
chew 2 chocolated pieces once or twice daily
children 6 to under 12 years of age
chew 1 chocolated piece once or twice daily
children under 6 years of age
ask a doctor

Other Information

  • Each piece contains: potassium 5 mg
  • Contains milk and soy ingredients
  • Store at 15°-25°C (59°-77°F)

Inactive Ingredients

Cocoa powder, hydrogenated vegetable oils (palm, palm kernel), salt, soy lecithin (an emulsifier), sugar, vanilla, and whey powder (milk)

* Please review the disclaimer below.