NDC 58980-410 Stratuscare Adult Glycerin

Glycerin

NDC Product Code 58980-410

NDC CODE: 58980-410

Proprietary Name: Stratuscare Adult Glycerin 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: Glycerin 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.

  • This product is used to relieve occasional constipation. Glycerin belongs to a class of drugs known as hyperosmotic laxatives. It works by drawing water into the intestines. This effect usually results in a bowel movement within 15 to 60 minutes. For adults, the normal frequency of bowel movements varies from once daily to 1 to 2 times weekly. For preschool-aged children, the normal frequency of bowel movements varies from once daily to once every other day. Constipation is best treated by drinking plenty of fluids, eating foods high in fiber, and exercising regularly.

NDC Code Structure

NDC 58980-410-12

Package Description: 12 SUPPOSITORY in 1 JAR

NDC 58980-410-25

Package Description: 25 SUPPOSITORY in 1 JAR

NDC 58980-410-50

Package Description: 50 SUPPOSITORY in 1 JAR

NDC Product Information

Stratuscare Adult Glycerin with NDC 58980-410 is a a human over the counter drug product labeled by Stratus Pharmaceuticals. The generic name of Stratuscare Adult Glycerin is glycerin. The product's dosage form is suppository and is administered via rectal form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 104155.

Dosage Form: Suppository - A solid body of various weights and shapes, adapted for introduction into the rectal orifice of the human body; they usually melt, soften, or dissolve at body temperature.

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.

Stratuscare Adult Glycerin 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.

  • WATER (UNII: 059QF0KO0R)
  • SODIUM STEARATE (UNII: QU7E2XA9TG)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Rectal - Administration to the rectum.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Stratus Pharmaceuticals
Labeler Code: 58980
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: 05-30-2014 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: 12-31-2021 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.

Stratuscare Adult Glycerin Product Label Images

Stratuscare Adult Glycerin 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

Other

Drug Facts

Distributed by:Stratus Pharmaceuticals Inc12379 SW 130th StreetMiami, Florida 33186

Active Ingredient (Per Suppository)

Glycerin, USP 2 g

Purpose

Laxative

Use

  • For relief of occasional constipation (irregularity)generally produces bowel movement in ¼ to 1 hour.

Warnings

For rectal use only.May cause rectal discomfort or burning sensation.

Otc - Ask Doctor

  • Ask a doctor before use if you have:abdominal pain, nausea or vomitinga sudden change in bowel habits lasting more than 2 weeks.

Otc - Stop Use

  • Stop use and ask a doctor:if you have rectal bleeding or fail to have a bowel movement after using a laxative. This may indicate a serious condition.

Otc - Do Not Use

  • Do not use laxative products for longer than 1 week unless directed by a doctor

Otc - Pregnancy Or Breast Feeding

  • If pregnant or breastfeeding, ask a doctor before use.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1212).

Directions

  • Adults and children 6 years and over: Carefully insert one suppository well into rectumIt need not melt completely to produce laxative actionGenerally produces bowel movement in 15 minutes to 1 hourDo not exceed one suppository daily unless directed by a doctorChildren under 6 years old: do not use

Other Information

  • Store glycerin suppositories at room temperature, between 15°C and 30°C (between 59°F and 86°F)Keep container tightly closed

Inactive Ingredients

Purified water, sodium stearate

* Please review the disclaimer below.