FDA.reportPublic FDA data

Docusate Mini Enema

Manufacturer
Major Pharmaceuticals
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:19:57

Label at a glance#

ProductDocusate Mini Enema
Active ingredientDOCUSATE SODIUM
Label structure13 sections

Indications and uses

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

Dosage and administration

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, la...

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (per delivered-dose)

Docusate Sodium USP 283 mg

Purpose

OTC - PURPOSE SECTION

Stool Softener Laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • 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:

OTC - ASK DOCTOR/PHARMACIST SECTION

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a healthcare professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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 SAFETY INFORMATION

Other Information Store at room temperature 15°-30° C (59°-86° F)

RETAIN BOTTLE FOR COMPLETE DRUG FACTS

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Glycerin USP and Polyethylene Glycol

OTC - QUESTIONS SECTION

Questions or Comments: (800) 616-2471

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1190184docusate sodium 283 MG in 5 mL EnemaPSN9
1190184docusate sodium 56.6 MG/ML EnemaSCD9
1190184DOSS sodium 283 MG per 5 ML EnemaSY9
1190184DOSS Sodium 56.6 MG/ML EnemaSY9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6920-93Docusate Mini Enema5 mL in 1 TUBELIQUID59
0904-6920-93Docusate Mini Enema30 in 1 JARLIQUID309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6920-93ML - Milliliter0904-6920fc220a58-bf2c-4750-8e0c-26561da84b5e12019-11-12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0904-69200904-6920-93

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT
GLYCERINPDC6A3C0OXIACT
DOCUSATE SODIUMF05Q2T2JA0ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Docusate Mini EnemaDOCUSATE SODIUMMajor Pharmaceuticals91099e15-94d7-b684-e053-2a95a90a574e2025-12-04WarningsExact identifier
ndc (package): 0904-6920-93
ndc (product): 0904-6920
ndc11 (package): 00904692093
spl id: 4524d961-37c9-20b3-e063-6294a90a54d0
spl set id: 91099e15-94d7-b684-e053-2a95a90a574e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.