Publix Laxative Maximum Strength
Calcium Sennosides
Publix Super Markets, Inc
Human Otc Drug
NDC 41415-114Publix Laxative Maximum Strength also known as Calcium Sennosides is a human otc drug labeled by 'Publix Super Markets, Inc'. National Drug Code (NDC) number for Publix Laxative Maximum Strength is 41415-114. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Publix Laxative Maximum Strength drug includes Sennosides A And B - 25 mg/1 . The currest status of Publix Laxative Maximum Strength drug is Active.
Drug Information:
| Drug NDC: | 41415-114 |
| 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: | Publix Laxative Maximum Strength |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Publix Laxative |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Maximum Strength |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Calcium Sennosides |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Publix Super Markets, Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| 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 A AND B - 25 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: | 15 May, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 05 May, 2026 |
| 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, 2023 |
| 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: | PUBLIX SUPER MARKETS, INC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 251292
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 1B5FPI42EN
|
| 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 |
|---|
| 41415-114-24 | 2 BLISTER PACK in 1 CARTON (41415-114-24) / 12 TABLET in 1 BLISTER PACK | 15 May, 2019 | 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:
Publix laxative maximum strength calcium sennosides sennosides a and b sennosides a and b acacia calcium sulfate anhydrous carnauba wax silicon dioxide starch, corn croscarmellose sodium dibasic calcium phosphate dihydrate fd&c blue no. 1 ferrosoferric oxide ferric oxide red ferric oxide yellow kaolin magnesium stearate maltodextrin microcrystalline cellulose polyethylene glycol, unspecified povidone, unspecified shellac stearic acid raw sugar talc titanium dioxide rp114
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 ⢠are taking a prescription 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 occurs after use of a laxative. these may be signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away at (1-800-222-1222).
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 ⢠are taking a prescription 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 occurs after use of a laxative. these may be signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away at (1-800-222-1222).
When Using:
When using this product, ⢠do not use for a period longer than 1 week.
Dosage and Administration:
Directions ⪠swallow pill(s) with a glass of water ⪠swallow pill(s) whole; do not crush, break, or chew adults and children 12 years and over take 2 tablets once or twice daily with a glass of water children 6 to under 12 years take1 tablet once or twice daily with a glass of water children under 6 years ask a doctor
Stop Use:
Stop use and ask a doctor if ⪠rectal bleeding or failure to have a bowel movement occurs after use of a laxative. these may be signs of a serious condition.
Package Label Principal Display Panel:
Principal display panel *compare to the active ingredient in ex-lax ® maximum strength tablets publix ® ndc# 41415-114-24 maximum strength laxative calcium sennosides usp 25 mg/ stimulant laxative 24 tablets tamper evident: do not use if any individual blister is broken or open. distributed by publix super markets, inc., 3300 publix corporate parkway lakeland, fl 33811 1-888-267-3037 publix.com publix guarantee: complete satisfaction or your money back maximum strength laxative calcium sennosides