NDC 70000-0443 Laxative

Sennosides

NDC Product Code 70000-0443

NDC Code: 70000-0443

Proprietary Name: Laxative Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.


Product Characteristics
Color(s):
BROWN (C48332 - TAN)
Shape: ROUND (C48348)
Size(s):
10 MM
Imprint(s):
44;347
Score: 1

Code Structure
  • 70000 - Cardinal Health
    • 70000-0443 - Laxative

NDC 70000-0443-1

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

NDC Product Information

Laxative with NDC 70000-0443 is a a human over the counter drug product labeled by Cardinal Health. The generic name of Laxative is sennosides. The product's dosage form is tablet, sugar coated and is administered via oral form.

Labeler Name: Cardinal Health

Dosage Form: Tablet, Sugar Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a colored or an uncolored water-soluble sugar.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Laxative Active Ingredient(s)

Additional informationCallout TooltipWhat 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 15 mg/1

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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)
  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • POVIDONE (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)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Cardinal Health
Labeler Code: 70000
FDA Application Number: part334 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 03-01-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Laxative Product Label Images

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 (In Each Tablet)

Sennosides USP, 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

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 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 (1-800-222-1222) right away.

Directions

  • Swallow tablet(s) with a glass of waterswallow tablet(s) whole; do not crush, break, or chew adults and children 12years and over2 tablets once ortwice dailychildren 6 to under12 years1 tablet once ortwice dailychildren under 6 yearsask a doctor

Other Information

  • Each tablet contains: calcium 45 mg, magnesium 5 mgTAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKENstore at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)see end flap for expiration date and lot number

Inactive Ingredients

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

* Please review the disclaimer below.

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