NDC 0067-8142 Ex-lax Maximum Strength Stimulant Laxative

Sennosides

NDC Product Code 0067-8142

NDC CODE: 0067-8142

Proprietary Name: Ex-lax Maximum Strength Stimulant Laxative 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):
BLUE (C48333)
Shape: ROUND (C48348)
Size(s):
10 MM
Imprint(s):
EX;LAX;1
Score: 1

NDC Code Structure

NDC 0067-8142-01

Package Description: 2 BLISTER PACK in 1 CARTON > 12 PILL in 1 BLISTER PACK

NDC 0067-8142-02

Package Description: 4 BLISTER PACK in 1 CARTON > 12 PILL in 1 BLISTER PACK

NDC Product Information

Ex-lax Maximum Strength Stimulant Laxative with NDC 0067-8142 is a a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Ex-lax Maximum Strength Stimulant Laxative is sennosides. The product's dosage form is pill and is administered via oral form.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc

Dosage Form: Pill - A small, round solid dosage form containing a medicinal agent intended for oral administration.

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.

Ex-lax Maximum Strength Stimulant Laxative 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 25 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.

  • ACACIA (UNII: 5C5403N26O)
  • CALCIUM CARBONATE (UNII: H0G9379FGK)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • POVIDONE, UNSPECIFIED (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)

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.
  • 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: Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code: 0067
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: 07-01-2017 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Ex-lax Maximum Strength Stimulant Laxative Product Label Images

Ex-lax Maximum Strength Stimulant Laxative 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

Sennosides, 25 mg

Purpose

Stimulant laxative

Uses

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

Do Not Use

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

Ask 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 with a glass of water •swallow tablet whole, do not crush, break or chewadults and children 12 years of age and older2 tablets once or twice dailychildren 6 to under 12 years of age1 tablet once or twice dailychildren under 6 years of ageask a doctor

Other Information

  • •each tablet contains: calcium 40 mg, magnesium 5 mg •store at controlled room temperature 20-25C (68-77F).

Inactive Ingredients

Acacia, calcium carbonate, carnauba wax, corrn starch dibasic calcium phosphate, FD&C blue no.1 aluminum lake, iron oxide black, magnesium stearate, methyl paraben, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, propylene glycol, propyl paraben, shellac, silicon dioxide, sodium benzoate, sodium lauryl sulfate, sucrose, talc, titanium dioxide

Questions?

Call 1-855-221-5432

Additional Information Listed On Other Panels

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.Distributed by: GlaxoSmithKline Consumer Healthcare Holdings (US), LLC. Warren, NJ 07059 ©20xx

* Please review the disclaimer below.