Docusate Mini Enema Liquid
FDA Label NDC 0904-6920

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Docusate Mini Enema (NDC 0904-6920). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, purpose, uses, warnings, do not use, stop use and ask a doctor if you:, pregnant or lactating women, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient (per delivered-dose)

Docusate Sodium USP 283 mg

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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