NDC 11822-7896 Maximum Strength Laxative

Sennosides

NDC Product Code 11822-7896

NDC CODE: 11822-7896

Proprietary Name: Maximum Strength 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):
9 MM
Score: 1

NDC Code Structure

  • 11822 - Rite Aid

NDC 11822-7896-4

Package Description: 96 TABLET, COATED in 1 CARTON

NDC Product Information

Maximum Strength Laxative with NDC 11822-7896 is a a human over the counter drug product labeled by Rite Aid. The generic name of Maximum Strength Laxative is sennosides. The product's dosage form is tablet, coated and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 251292.

Dosage Form: Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.

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.

Maximum Strength 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.


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)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • KAOLIN (UNII: 24H4NWX5CO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • POVIDONE (UNII: FZ989GH94E)
  • SHELLAC (UNII: 46N107B71O)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
  • FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • RAW SUGAR (UNII: 8M707QY5GH)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • TALC (UNII: 7SEV7J4R1U)

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: Rite Aid
Labeler Code: 11822
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: 12-31-2021 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: 12-31-2022 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 - NO 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".

* Please review the disclaimer below.

Maximum Strength 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

Otc - Active Ingredient

Active ingredient (in each tablet) Sennosides USP, 25 mg

Otc - Purpose

PurposeStimulant Laxative

Indications & Usage

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

Warnings

Warnings

Otc - Do Not Use

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

Otc - Ask Doctor

  • Ask a doctor before use if you have noticed a sudden change in bowel habits that persists over a period of 2 weeks

Otc - Ask Doctor/Pharmacist

  • 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.

Otc - When Using

  • When using this productdo not use for a period longer than 1 week

Otc - 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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

  • DirectionsSwallow tablets(s) with a glass of water.Swallow tablets(s) whole, do not crush, break, or chew.adults and children 12 years of age and older: take 2 tablets once or twice dailychildren 6 to under 12 years of age: take 1 tablet once or twice dailychildren under 6 years of age: ask a doctor

Other Safety Information

  • Other informationeach tablet contains: calcium 40 mg, sodium 2 mg (VERY LOW SODIUM)
  • Store between 20°-25°C (68°-77°F)

Inactive Ingredient

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, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, shellac, stearic acid, sugar, talc, titanium dioxide.

Otc - Questions

Questions or comments?call 1-877-290-4008

* Please review the disclaimer below.