NDC 0067-8141 Ex-lax Regular Strength Stimulant Laxative
Sennosides Tablet Oral

Product Information

Ex-lax Regular Strength Stimulant Laxative is a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Ex-lax Regular Strength Stimulant Laxative is sennosides. The product's dosage form is tablet and is administered via oral form.

Product Code0067-8141
Proprietary Name 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.
Ex-lax Regular Strength Stimulant Laxative
Non-Proprietary Name 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.
Sennosides
Product Type 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.
Human Otc Drug
Dosage FormTablet - A solid dosage form containing medicinal substances with or without suitable diluents.
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.
Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code0067
FDA Application Number 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.
part334
Marketing Category 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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
07-01-2017
Listing Expiration Date 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.
12-31-2022
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Ex-lax Regular Strength Stimulant Laxative?


Product Characteristics

Color(s)WHITE (C48325 - BEIGE)
BROWN (C48332 - TAN)
ShapeROUND (C48348)
Size(s)11 MM
10 MM
Imprint(s)EX;LAX;1
Score1

Product Packages

NDC 0067-8141-01

Package Description: 1 BLISTER PACK in 1 CARTON > 8 TABLET in 1 BLISTER PACK

NDC 0067-8141-02

Package Description: 2 BLISTER PACK in 1 CARTON > 15 TABLET in 1 BLISTER PACK

Product Details

What are Ex-lax Regular Strength Stimulant Laxative Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • SENNOSIDES 15 mg/1 - Medications derived from SENNA EXTRACT that are used to treat CONSTIPATION.

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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.
  • ACACIA (UNII: 5C5403N26O)
  • ALGINIC ACID (UNII: 8C3Z4148WZ)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SHELLAC (UNII: 46N107B71O)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SUCROSE (UNII: C151H8M554)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • ACACIA (UNII: 5C5403N26O)
  • CALCIUM CARBONATE (UNII: H0G9379FGK)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • POLYVINYL ALCOHOL (UNII: 532B59J990)
  • POVIDONES (UNII: FZ989GH94E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SHELLAC (UNII: 46N107B71O)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SUCROSE (UNII: C151H8M554)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

* Please review the disclaimer below.

Ex-lax Regular Strength Stimulant Laxative Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredient (In Each Tablet)



Sennosides 15 mg


Purpose



Stimulant laxative


Uses



  • •relieves occasional constipation (irregularity)
  • •generally produces bowel movement in 6 to 12 hours

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.


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


Other Information



  • each tablet contains: calcium 45 mg, magnesium 5mg
  • •store at controlled room temperature 20-25°C (68-77°F)

Inactive Ingredients (0067-0003)



acacia, alginic acid, carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate, iron oxides, magnesium stearate, microcrystalline cellulose, potassium hydroxide, pregelatinized starch, propylene glycol, shellac, sodium benzoate, sodium lauryl sulfate, stearic acid, sucrose, talc, titanium dioxide


Inactive Ingredients (0067-8141)



acacia, calcium carbonate, carnauba wax, corn starch, dibasic calcium phosphate, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, methylparaben, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, propylparaben, shellac, silicon dioxide, sodium benzoate, sodium lauryl sulfate, sucrose, talc, titanium dioxide


Questions ?



call 1-855-221-5432


Principal Display Panel



NDC 0067-0003-30

Regular Strength

ex•lax®

SENNOSIDES, USP, 15 mg

STIMULANT LAXATIVE

RELIEF GUARANTEED EVERY TIME

GENTLE OVERNIGHT RELIEF YOU CAN TRUST

The Ex•Lax® Guarantee: When taken as directed, Ex•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: Ex•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 Consuemr Health, Inc.

Parsippany, NJ 07054-0622

NDC 0067-8141-02

ex•lax®

SENNOSIDES, 15 mg

REGULAR STRENGTH

STIMULANT LAXATIVE

RELIEF GUARANTEED

GENTLE OVERNIGHT RELIEF YOU CAN TRUST

The Ex•Lax® Guarantee: When taken as directed, Ex•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: Ex•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


* Please review the disclaimer below.