Chocolated Laxative
Sennosides Stimulant Laxative
Walgreens
Human Otc Drug
NDC 0363-5000Chocolated Laxative also known as Sennosides Stimulant Laxative is a human otc drug labeled by 'Walgreens'. National Drug Code (NDC) number for Chocolated Laxative is 0363-5000. This drug is available in dosage form of Tablet, Chewable. The names of the active, medicinal ingredients in Chocolated Laxative drug includes Sennosides - 15 mg/1 . The currest status of Chocolated Laxative drug is Active.
Drug Information:
| Drug NDC: | 0363-5000 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Chocolated Laxative |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Sennosides Stimulant Laxative |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Walgreens |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Chewable |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | SENNOSIDES - 15 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 10 Apr, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part334 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2024 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Walgreens
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0311917166636
|
| UPC stands for Universal Product Code. |
| UNII: | 3FYP5M0IJX
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0363-5000-24 | 2 POUCH in 1 CARTON (0363-5000-24) / 12 TABLET, CHEWABLE in 1 POUCH | 10 Apr, 2014 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose stimulant laxative
Product Elements:
Chocolated laxative sennosides stimulant laxative sennosides sennosides cocoa cotton seed palm kernel oil sodium chloride lecithin, soybean sucrose vanilla whey cl
Indications and Usage:
Uses relieves occasional constipation (irregularity) generally produces bowel movement in 6 to 12 hours
Warnings:
Warnings 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. if pregnant or breastfeeding, ask a health professional before use. keep out of reach of children. in case of overdoes, get medical help or contact a poison control center (1-800-222-1222) right away.
Do Not Use:
Warnings 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. if pregnant or breastfeeding, ask a health professional before use. keep out of reach of children. in case of overdoes, get medical help or contact a poison control center (1-800-222-1222) right away.
When Using:
When using this product do not use for a period longer than 1 week
Dosage and Administration:
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
Stop Use:
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.
Package Label Principal Display Panel:
Principal display panel 24 pieces carton label ndc 0363-5000-24 walgreens compare to the active ingredient in ex-lax ® chocolate stimulant laxative sennosides, usp, 15 mg / stimulant laxative regular strength relieves occasional constipation 24 pieces actual size chocolate flavored principal display panel 24 pieces carton label
Further Questions:
Questions or comments? 1-800-walgreens (1-800-925-4733)