Ex-lax Regular Strength Stimulant Laxative
Sennosides
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Human Otc Drug
NDC 0067-8141Ex-lax Regular Strength Stimulant Laxative also known as Sennosides is a human otc drug labeled by 'Glaxosmithkline Consumer Healthcare Holdings (us) Llc'. National Drug Code (NDC) number for Ex-lax Regular Strength Stimulant Laxative is 0067-8141. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Ex-lax Regular Strength Stimulant Laxative drug includes Sennosides - 15 mg/1 . The currest status of Ex-lax Regular Strength Stimulant Laxative drug is Active.
Drug Information:
| Drug NDC: | 0067-8141 |
| 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: | Ex-lax Regular Strength Stimulant Laxative |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Ex-lax |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | REGULAR STRENGTH STIMULANT LAXATIVE |
| 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: | Sennosides |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Glaxosmithkline Consumer Healthcare Holdings (us) Llc |
| 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 - 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: | 01 Jul, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 14 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: | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 200162
213072
|
| 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: | 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 |
|---|
| 0067-8141-01 | 1 BLISTER PACK in 1 CARTON (0067-8141-01) / 8 TABLET in 1 BLISTER PACK | 01 Jul, 2017 | N/A | No |
| 0067-8141-02 | 2 BLISTER PACK in 1 CARTON (0067-8141-02) / 15 TABLET in 1 BLISTER PACK | 01 Jul, 2017 | 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:
Ex-lax regular strength stimulant laxative sennosides sennosides sennosides acacia alginic acid carnauba wax silicon dioxide anhydrous dibasic calcium phosphate ferrosoferric oxide ferric oxide red ferric oxide yellow magnesium stearate microcrystalline cellulose potassium hydroxide propylene glycol shellac sodium benzoate sodium lauryl sulfate stearic acid sucrose talc titanium dioxide beige ex;lax;1 ex-lax regular strength stimulant laxative sennosides sennosides sennosides acacia calcium carbonate carnauba wax starch, corn anhydrous dibasic calcium phosphate ferrosoferric oxide ferric oxide red ferric oxide yellow magnesium stearate methylparaben microcrystalline cellulose polyethylene glycol, unspecified polyvinyl alcohol, unspecified povidone, unspecified propylene glycol propylparaben shellac silicon dioxide sodium benzoate sodium lauryl sulfate sucrose talc titanium dioxide tan ex;lax;1
Indications and Usage:
Uses ⢠relieves occasional constipation (irregularity) ⢠generally produces bowel movement in 6 to 12 hours
Warnings:
Warning s 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 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.
Do Not Use:
Warning s 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 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.
When Using:
When using this product do not use for a period longer than 1 week
Dosage and Administration:
Directions ⢠swallow tablet(s) with a glass of water ⢠swallow tablet(s) whole, do not crush, break or chew adults and children 12 years of age and older 2 tablets once or twice daily children 6 to under 12 years of age 1 tablet 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 ndc 0067-0003-30 regular strength exâ¢lax® sennosides, usp, 15 mg stimulant laxative relief guaranteed every time gentle overnight relief you can trust the exâ¢lax® guarantee: when taken as directed, exâ¢lax® is guaranteed to work gently and effectively overnight or your money back. return product to novartis, attention consumer affairs, for full refund. tamper evident feature: exâ¢lax® pills are sealed in blister packets. use only if the individual seal is unbroken. trademarks are owned by or licensed to gsk group of companies distributed by: novartis consumer health, inc. parsippany, nj 07054-0622 ex-lax rs pills pdp
Principal display panel ndc 0067-8141-02 exâ¢lax® sennosides, 15 mg regular strength stimulant laxative relief guaranteed gentle overnight relief you can trust the exâ¢lax® guarantee: when taken as directed, exâ¢lax® is guaranteed to work gently and effectively overnight or your money back. return product to gsk, attention consumer affairs, for full refund. tamper evident feature: exâ¢lax® tablets are sealed in blister packets. use only if the individual seal is unbroken. trademarks are owned by or licensed to the gsk group of companies. distributed by: gsk consumer healthcare warren, nj 07059 ©2017 gsk or its licensor. all rights reserved 13143 exlax regular strength tablet 30 count carton
Further Questions:
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