NDC 41520-142 Laxative Pills Maximum Strength

Sennosides

NDC Product Code 41520-142

NDC Code: 41520-142

Proprietary Name: Laxative Pills Maximum Strength 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.

Product Characteristics

Color(s):
BLUE (C48333)
Shape: ROUND (C48348)
Size(s):
10 MM
Imprint(s):
TCL083;S25
Score: 1

NDC Code Structure

  • 41520 - Care One (american Sales Company)

NDC 41520-142-24

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

NDC Product Information

Laxative Pills Maximum Strength with NDC 41520-142 is a a human over the counter drug product labeled by Care One (american Sales Company). The generic name of Laxative Pills Maximum Strength is sennosides. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Care One (american Sales Company)

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.

Laxative Pills Maximum Strength 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 SULFATE ANHYDROUS (UNII: E934B3V59H)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • KAOLIN (UNII: 24H4NWX5CO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • POVIDONES (UNII: FZ989GH94E)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • SHELLAC (UNII: 46N107B71O)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SUCROSE (UNII: C151H8M554)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • TARTARIC ACID (UNII: W4888I119H)

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.

Labeler Name: Care One (american Sales Company)
Labeler Code: 41520
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: 08-05-2010 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 01-01-2022 What is the End Marketing Date?
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.

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.

Information for Patients

Senna

Senna is


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Senna

Senna is pronounced as (sen' a)
Why is senna medication prescribed?
Senna is used on a short-term basis to treat constipation. It also is used to empty the bowels before surgery and certain medical procedures. Senna is in a class of medic...
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* Please review the disclaimer below.

Laxative Pills Maximum Strength Product Label Images

Laxative Pills Maximum Strength 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, 25 mg

Purpose

Stimulant laxative

Uses

  • Relief of occasional constipation (irregularity). This product generally produces bowel movement within 6 to 12 hours.

Do Not Use

  • When abdominal pain, nausea, or vomiting are presentfor longer than 1 week, unless directed by a doctor

Ask A Doctor Before Use If

  • You notice a sudden change in bowel habits that persists over a period of 2 weeks

Stop Use And Ask A Doctor If

  • You have rectal bleeding
  • You fail to have a bowel movement after use. These may be signs of a serious condition.

If Pregnant Or Breast-Feeding,

Ask a health care 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

Adults and children 12 years of age and older take 2 tablets once or twice daily with a glass of water  children 6 to under 12 years of age  take 1 tablet once or twice daily with a glass of water  children under 6 years of ageconsult a doctor

Other Information

  • Each tablet contains: calcium 40 mg/ tableteach tablet contains: magnesium 10 mg/ tableteach tablet contains: sodium 3 mg/ tablet VERY LOW SODIUM
  • Store at 15º - 30º C (59º-86º F)
  • Keep in a dry place
  • Do not expose to excessive heat
  • *This product is not manufactured or distributed by Novartis Consumer Health Inc., owner of the registered trademark Ex-Lax®

Inactive Ingredients

Acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C Blue #1 Aluminum Lake, iron oxide, iron oxide Black, iron oxide Yellow, kaolin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, shellac, sodium lauryl sulfate, stearic acid, sugar, talc, and titanium dioxide. May also contain:  anhydrous lactose, isopropyl alcohol, Lake Brilliant Blue FCF, malto dextrin, Opacode Black S-1-17823, Opagloss 6000P, tartaric acid

Product Label

Sennosides 25 mg

* Please review the disclaimer below.