NDC 0904-6920 Docusate Mini Enema

Docusate Sodium

NDC Product Code 0904-6920

NDC 0904-6920-93

Package Description: 30 TUBE in 1 JAR > 5 mL in 1 TUBE

NDC Product Information

Docusate Mini Enema with NDC 0904-6920 is a a human over the counter drug product labeled by Major Pharmaceuticals. The generic name of Docusate Mini Enema is docusate sodium. The product's dosage form is liquid and is administered via rectal form.

Labeler Name: Major Pharmaceuticals

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Docusate Mini Enema 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.

  • DOCUSATE SODIUM 283 mg/5mL

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.

  • POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
  • GLYCERIN (UNII: PDC6A3C0OX)

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: Major Pharmaceuticals
Labeler Code: 0904
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: 08-26-2019 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’.

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Docusate Mini Enema Product Label Images

Docusate Mini Enema 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

Drug Facts

Active Ingredient (per delivered-dose)Docusate Sodium USP 283 mg

Purpose

Stool Softener Laxative

Uses

  • For relief of occasional constipation (irregularity).This product generally produces a bowel movement in 2 to 15 minutes.

Warnings

For rectal use only. Drug Interaction Precaution: Do not take this product if you are presently taking mineral oil, unless directed by a doctor.

Do Not Use

  • Laxative products when abdominal pain, nausea or vomiting are present.Laxative products for a period longer than 1 week unless directed by a doctor.

Stop Use And Ask A Doctor If You:

  • Rectal bleeding.Noticed a sudden change in bowel habits that persists over a period of 2 weeks.Failed to have a bowel movement after use. This may indicate a serious condition.

Pregnant Or Lactating Women

Ask a healthcare professional before use.

Keep Out Of Reach Of Children

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

  • Adults and children 12 years of age and older (with adult supervision) one to three units daily. Children under 12 years of age, consult a doctor prior to use.Twist off and remove tip.Lubricate tip prior to insertion: Place a few drops of the tube's liquid content on the shaft prior to insertion. Also apply liquid content or lubricant to the anus before inserting the mini-enema.Positioning: For best results, lay on the left side with knees bent. Insert slowley into rectum, up to shoulder of tube. Alternate Positions: Administer while seated on the toilet. Or, kneel, then lower head and chest forward until side of face is resting on the surface.With steady pressure, gently insert the tube into the rectum with care to prevent damage to the rectal wall. Squeeze to empty the contents. Keep the tube squeezed until it is removed from the rectum. After the contents have been emptied, remove the disposable tube and discard. A small amount of liquid may remain in the unit after use.

Other Information

Other Information Store at room temperature 15°-30° C (59°-86° F)
RETAIN BOTTLE FOR COMPLETE DRUG FACTS

Inactive Ingredients

Glycerin USP and Polyethylene Glycol

Otc - Questions

Questions or Comments: (800) 616-2471

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