Cvshealth Ready-to-use Mini Enema

Cvshealth Ready-to-use Mini Enema
SPL v5
SPL
SPL Set ID ca00c520-410a-1905-e053-2995a90a56f0
Route
RECTAL
Published
Effective Date 2021-08-20
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 2021-08-20

Description

Active Ingredients (per delivered dose) Benzocaine 20 mg Docusate Sodium USP 283 mg

Purpose

(Benzocaine).............. Anesthetic (Docusate Sodium).... Stool Softener Laxative


Medication Information

Purpose

(Benzocaine).............. Anesthetic

(Docusate Sodium).... Stool Softener Laxative

Description

Active Ingredients (per delivered dose) Benzocaine 20 mg Docusate Sodium USP 283 mg

Uses
  • For the 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

Section 53414-9

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

Warnings

For rectal use only.

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. 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. Insert up to the shoulder of tube. 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
  • If individual is sensitive to Benzocaine
  • If you are presently taking mineral oil, unless directed by a doctor.
  • When abdominal pain, nausea or vomiting are present.
  • For a period longer than 1 week unless directed by a doctor.
Drug Facts

Active Ingredients (per delivered dose)

Benzocaine 20 mg

Docusate Sodium USP 283 mg

Other Information

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

Inactive Ingredients

Glycerin USP and Polyethylene Glycol

Stop Use and Ask A Doctor If:
  • Symptoms last more than 2 weeks.
  • You have rectal bleeding or fail to have a bowel movement after use. This may indicate a serious condition.

Structured Label Content

Uses
  • For the 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)

Section 53414-9 (53414-9)

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

Purpose

(Benzocaine).............. Anesthetic

(Docusate Sodium).... Stool Softener Laxative

Warnings

For rectal use only.

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. 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. Insert up to the shoulder of tube. 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)
  • If individual is sensitive to Benzocaine
  • If you are presently taking mineral oil, unless directed by a doctor.
  • When abdominal pain, nausea or vomiting are present.
  • For a period longer than 1 week unless directed by a doctor.
Drug Facts

Active Ingredients (per delivered dose)

Benzocaine 20 mg

Docusate Sodium USP 283 mg

Other Information

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

Inactive Ingredients

Glycerin USP and Polyethylene Glycol

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)
  • Symptoms last more than 2 weeks.
  • You have rectal bleeding or fail to have a bowel movement after use. This may indicate a serious condition.

Advanced Ingredient Data


Raw Label Data

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