Enemeez® Plus

Enemeez® Plus
SPL v21
SPL
SPL Set ID 1670ca59-7275-4ac6-bef4-674a7b24c7b3
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) Benzocaine (20 mg)
Inactive Ingredients
Polyethylene Glycol 300 Glycerin

Identifiers & Packaging

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

Description

Active ingredient (per mini enema) Docusate Sodium USP 283 mg Benzocaine 20mg


Medication Information

Description

Active ingredient (per mini enema) Docusate Sodium USP 283 mg Benzocaine 20mg

Uses

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

Section 34088-5

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

Section 42229-5

Manufactured by:

Enemeez, Inc., Phoenix, AZ 85050

Distributed by:

Alliance Labs, L.L.C

2515 E. Rose Garden Lane, Suite #1

Phoenix, AZ 85050

Section 50565-1

Keep out of reach of children.

Section 50568-5

Ask a doctor or pharmacist before use if you are presently taking mineral oil.

Section 51945-4

Section 53413-1

Questions or Comments: 1-888-273-9734 or www.enemeez.com

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Docusate Sodium USP 283 mg ............. Stool Softener Laxative

Benzocaine 20mg ................................ Anesthetic

Warnings

For rectal use only. This is not a suppository. Do not take orally. Individuals with sensitivity to Benzocaine should not use this product.

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 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.
Drug Facts

Active ingredient (per mini enema)

Docusate Sodium USP 283 mg

Benzocaine 20mg

Other Information

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

Inactive Ingredients

Inactive Ingredients Polyethylene Glycol and Glycerin USP

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.
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.

Structured Label Content

Uses

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

Section 34088-5 (34088-5)

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

Section 42229-5 (42229-5)

Manufactured by:

Enemeez, Inc., Phoenix, AZ 85050

Distributed by:

Alliance Labs, L.L.C

2515 E. Rose Garden Lane, Suite #1

Phoenix, AZ 85050

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are presently taking mineral oil.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or Comments: 1-888-273-9734 or www.enemeez.com

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Docusate Sodium USP 283 mg ............. Stool Softener Laxative

Benzocaine 20mg ................................ Anesthetic

Warnings

For rectal use only. This is not a suppository. Do not take orally. Individuals with sensitivity to Benzocaine should not use this product.

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 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.
Drug Facts

Active ingredient (per mini enema)

Docusate Sodium USP 283 mg

Benzocaine 20mg

Other Information

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

Inactive Ingredients

Inactive Ingredients Polyethylene Glycol and Glycerin USP

Stop Use and Ask A Doctor If You: (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.
Ask A Doctor Before Use If You Have: (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.

Advanced Ingredient Data


Raw Label Data

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