013 Pure & Gentle Mineral Oil Enema

013 Pure & Gentle Mineral Oil Enema
SPL v8
SPL
SPL Set ID 96d4cad5-0602-4c31-94ed-3117b4fd4a94
Route
RECTAL
Published
Effective Date 2019-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Mineral Oil (100 g)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-04-09

Description

Mineral oil 100% w/v

Purpose

Lubricant laxative


Medication Information

Purpose

Lubricant laxative

Description

Mineral oil 100% w/v

Uses
  • for relief of occasional constipation
  • this product generally produces bowel movement in 2 to 15 minutes
Warnings

For rectal use only

Caution: to be taken only at bedtime. Do not use at any other time or administer to infants, except upon the advice of a physician.

Directions

Rectal enema dosage is 120 mL in a single daily dosage (per 24 hours)

adults & children

13 years and over

1 bottle

children under 13 years of age

DO NOT USE

Caution:

Remove green protective shield before inserting: hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with other hand and pull gently to remove

Positioning:

Left-side position: Lie on left side with knee bent and arms at rest.

Knee-chest position: Kneel, then lower head and chest forward until left side of face is resting on surface. Position arms comfortably.

Administering enema:

  • With steady pressure, gently insert enema tip into rectum with a slight side-to-side movement, with tip pointing toward navel. Insertion may be easier if person receiving enema bears down, as if having a bowel movement. This helps relax the muscles around the anus.
  • Do not force the enema tip into rectum as this can cause injury.
  • Squeeze bottle until nearly all liquid is gone. It is not necessary to empty the bottle completely, as it contains more liquid than needed.
  • Remove enema tip from rectum. This product generally produces a bowel movement in 2 to 15 minutes.
  • Do not retain enema solution in body for longer than 15 minutes.
Do Not Use
  • on children under 13 years of age
  • on pregnant women
  • on persons with difficulty swallowing
  • on bedridden patients
  • if you are presently taking a stool softener laxative
  • or take with meals
Package Label

Active Ingredient

Mineral oil 100% w/v

Other Information
  • store at room temperature 15-30°C (59-86°F)
  • Tamper Evident: DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING.
Inactive Ingredient

none

Questions Or Comments?

1-866-323-0107 M-F 8 am to 5 pm

Manufacturing Information

Manufactured for: Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093

Made in USA

www.medline.com

1-800-MEDLINE (633-5463)

REF: CUR095010

V1 RD22NPX

Stop Use and Ask A Doctor If
  • you have rectal bleeding
  • you have no bowel movement within 30 minutes of enema use
Ask A Doctor Before Use If You
  • have already used a laxative for more than 3 days
  • have abdominal pain, nausea or vomiting
  • have a sudden change in bowel habits that persists over a period of 2 weeks
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

As With Any Drug, If You Are Nursing A Baby,

seek the advice of a health professional before using this product.


Structured Label Content

Uses
  • for relief of occasional constipation
  • this product generally produces bowel movement in 2 to 15 minutes
Purpose

Lubricant laxative

Warnings

For rectal use only

Caution: to be taken only at bedtime. Do not use at any other time or administer to infants, except upon the advice of a physician.

Directions

Rectal enema dosage is 120 mL in a single daily dosage (per 24 hours)

adults & children

13 years and over

1 bottle

children under 13 years of age

DO NOT USE

Caution:

Remove green protective shield before inserting: hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with other hand and pull gently to remove

Positioning:

Left-side position: Lie on left side with knee bent and arms at rest.

Knee-chest position: Kneel, then lower head and chest forward until left side of face is resting on surface. Position arms comfortably.

Administering enema:

  • With steady pressure, gently insert enema tip into rectum with a slight side-to-side movement, with tip pointing toward navel. Insertion may be easier if person receiving enema bears down, as if having a bowel movement. This helps relax the muscles around the anus.
  • Do not force the enema tip into rectum as this can cause injury.
  • Squeeze bottle until nearly all liquid is gone. It is not necessary to empty the bottle completely, as it contains more liquid than needed.
  • Remove enema tip from rectum. This product generally produces a bowel movement in 2 to 15 minutes.
  • Do not retain enema solution in body for longer than 15 minutes.
Do Not Use (Do not use)
  • on children under 13 years of age
  • on pregnant women
  • on persons with difficulty swallowing
  • on bedridden patients
  • if you are presently taking a stool softener laxative
  • or take with meals
Package Label

Active Ingredient (Active ingredient)

Mineral oil 100% w/v

Other Information
  • store at room temperature 15-30°C (59-86°F)
  • Tamper Evident: DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING.
Inactive Ingredient (Inactive ingredient)

none

Questions Or Comments? (Questions or comments?)

1-866-323-0107 M-F 8 am to 5 pm

Manufacturing Information

Manufactured for: Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093

Made in USA

www.medline.com

1-800-MEDLINE (633-5463)

REF: CUR095010

V1 RD22NPX

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you have rectal bleeding
  • you have no bowel movement within 30 minutes of enema use
Ask A Doctor Before Use If You (Ask a doctor before use if you)
  • have already used a laxative for more than 3 days
  • have abdominal pain, nausea or vomiting
  • have a sudden change in bowel habits that persists over a period of 2 weeks
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

As With Any Drug, If You Are Nursing A Baby, (As with any drug, if you are nursing a baby,)

seek the advice of a health professional before using this product.


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Raw Label Data

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