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  5. Label Information: Docusate Mini Enema

FDA Label for Docusate Mini Enema

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. STOP USE AND ASK A DOCTOR IF YOU:
    7. PREGNANT OR LACTATING WOMEN
    8. KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. OTC - QUESTIONS
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Docusate Mini Enema Product Label

The following document was submitted to the FDA by the labeler of this product Major Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


Package Label.Principal Display Panel



pdp - MajorPDP

pdp - MajorPDP


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