Enemeez ®

Enemeez ®
SPL v18
SPL
SPL Set ID 0b06445d-0839-497e-bdff-e0fe224a7738
Route
RECTAL
Published
Effective Date 2022-11-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (283 mg)
Inactive Ingredients
Polyethylene Glycol 300 Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-06-15

Description

Active ingredient (per delivered dose) Docusate Sodium USP 283 mg

Purpose

Stool Softener Laxative


Medication Information

Purpose

Stool Softener Laxative

Description

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.
Section 50565-1

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

Section 51945-4

Principal Display Panels:

Section 53414-9

Pregnant or Lactating Women, ask a healthcare professional before use.

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.

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 left side with knees bent. Insert slowly into rectum, up to the 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.

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.
Drug Facts

Active ingredient (per delivered dose)

Docusate Sodium USP 283 mg

Other Information

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

Inactive Ingredients

Glycerin USP and Polyethylene Glycol

Questions Or Comments:

(888) 273-9734 or www.enemeez.com

Manufactured by:

Summit Pharmaceuticals, Inc.

Phoenix, AZ 85027

Distributed by:

Alliance Labs, LLC.

Phoenix, AZ 85027

Stop Use and Ask A Doctor If You Have:
  • 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.

Structured Label Content

Uses
  • For relief of occasional constipation (irregularity).
  • This product generally produces a bowel movement in 2 to 15 minutes.
Section 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

Principal Display Panels:

Section 53414-9 (53414-9)

Pregnant or Lactating Women, ask a healthcare professional before use.

Purpose

Stool Softener Laxative

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.

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 left side with knees bent. Insert slowly into rectum, up to the 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.

Do Not Use (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.
Drug Facts

Active ingredient (per delivered dose)

Docusate Sodium USP 283 mg

Other Information

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

Inactive Ingredients

Glycerin USP and Polyethylene Glycol

Questions Or Comments: (Questions or Comments:)

(888) 273-9734 or www.enemeez.com

Manufactured by:

Summit Pharmaceuticals, Inc.

Phoenix, AZ 85027

Distributed by:

Alliance Labs, LLC.

Phoenix, AZ 85027

Stop Use and Ask A Doctor If You Have: (Stop use and ask a doctor if you have:)
  • 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.

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)