Label: DOCUSATE MINI ENEMA- docusate sodium liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 10, 2020

If you are a consumer or patient please visit this version.

  • 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

  • QUESTIONS

    Questions or Comments: (800) 616-2471

  • PRINCIPAL DISPLAY PANEL

    pdp

  • INGREDIENTS AND APPEARANCE
    DOCUSATE MINI ENEMA 
    docusate sodium liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6920
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM283 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-6920-9330 in 1 JAR08/26/2019
    15 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33408/26/2019
    Labeler - Major Pharmaceuticals (191427277)