FDA Label for Enemeez
View Indications, Usage & Precautions
Enemeez Product Label
The following document was submitted to the FDA by the labeler of this product Enemeez Llc Dba Summit 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 mini enema)
Docusate Sodium USP 283 mg
Uses
For relief of occasional constipation (irregularity). This product generally produces a stimulus and bowel movement in 2 to 15 minutes.
Warnings
For rectal use only. This is not a suppository. Do not take orally.
Ask A Doctor Before Use If You Have:
- abdominal pain, nausea or vomiting.
- a sudden change in bowel habits that persists over a period of 2 weeks.
Stop Use And Ask A Doctor If You:
- have rectal bleeding.
- failed to have a bowel movement after use. This may indicate a serious condition.
- encounter resistance. Forcing the tube may result in injury or damage to the rectum. If product is not administered properly and occasional rectal examinations are not performed, serious complications can arise. Occasional rectal exams are imperative for patients with impaired rectal function, especially loss of sensation.
- require a bowel program for longer than 1 week.
- experience rectal irritation or a rash around the anus appears.
Directions
Adults and children 12 years of age and older (with adult supervision) one to three units daily. Children 2 years and over but not more than 12 years should consult a doctor prior to use and not exceed one unit daily (with adult supervision).
Twist off and remove tip; Lubricate tip prior to insertion: Place a few drops of water or the product on the shaft prior to insertion. Also apply one of these lubricants to the anus before inserting the enema. With steady pressure, gently insert the tube into the rectum with care to prevent damage to the rectal wall. Squeeze to empty the contents. Continue squeezing the tube until it is removed from the rectum. Remove the disposable tube and discard. A small amount of liquid may remain in the tube after use.
Positioning:
For best results, lay on the left side with knees bent.
Alternate Positions:
- Administer while seated on the toilet.
- Kneel with the left arm folded comfortably, then lower head and chest forward until side of face is resting on the surface.
Other Information
Other Information Store at room temperature 15°-30° C (59°-86° F)
Inactive Ingredients
Inactive Ingredients Polyethylene Glycol and Glycerin USP
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