Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 9788c057-665e-4352-b03a-022259e5ae76
Route
RECTAL
Published
Effective Date 2011-08-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Mineral Oil (118 mL)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-07-16

Description

(in each 118 mL delivered dose) Mineral oil 100%

Purpose

Lubricant laxative


Medication Information

Purpose

Lubricant laxative

Description

(in each 118 mL delivered dose) Mineral oil 100%

Uses
  • for relief of occasional constipation
Warnings

For rectal use only

Directions

Single daily dose

adults & children

12 years and over

1 bottle once daily

children 2 to under

12 years

1/2 bottle once daily

children under

2 years

do not use

How to use this enema:

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.
  • Retain enema in accordance with doctor's instructions.
Active Ingredient

(in each 118 mL delivered dose)

Mineral oil 100%

Other Information
  • store at room temperature 20-25 deg C (68-77 deg F)
  • this product generally produces bowel movement in 2-15 minutes
Inactive Ingredient

none

Questions Or Comments?

1-800-633-5463

Side and Back Panel Box
Stop Use and Ask A Doctor If
  • you have rectal bleeding or failure to have a bowel movement after use of a laxative because this may indicate a serious condition
  • you need to use a laxative for more than one week
Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Ask A Doctor Before Use If You Have
  • abdominal pain, nausea or vomiting
  • notice a sudden change in bowel habits that persists over a period of 2 weeks
Side and Principal Display Panel Box

NDC 46122-600-11

Good Neighbor Pharmacy

Ready-to-Use

ENEMA

MINERAL OIL

  •  
    Sodium free lubricant laxative for relief of occasional constipation
  •  
    Comfortable lubricated tip
  •  
    Works in minutes
  •  
    LATEX FREE

4.5 FL OZ (133 ml)


Structured Label Content

Uses
  • for relief of occasional constipation
Purpose

Lubricant laxative

Warnings

For rectal use only

Directions

Single daily dose

adults & children

12 years and over

1 bottle once daily

children 2 to under

12 years

1/2 bottle once daily

children under

2 years

do not use

How to use this enema:

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.
  • Retain enema in accordance with doctor's instructions.
Active Ingredient (Active ingredient)

(in each 118 mL delivered dose)

Mineral oil 100%

Other Information
  • store at room temperature 20-25 deg C (68-77 deg F)
  • this product generally produces bowel movement in 2-15 minutes
Inactive Ingredient (Inactive ingredient)

none

Questions Or Comments? (Questions or comments?)

1-800-633-5463

Side and Back Panel Box (Side and Back Panel - Box)
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you have rectal bleeding or failure to have a bowel movement after use of a laxative because this may indicate a serious condition
  • you need to use a laxative for more than one week
Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • abdominal pain, nausea or vomiting
  • notice a sudden change in bowel habits that persists over a period of 2 weeks
Side and Principal Display Panel Box (Side and Principal Display Panel - Box)

NDC 46122-600-11

Good Neighbor Pharmacy

Ready-to-Use

ENEMA

MINERAL OIL

  •  
    Sodium free lubricant laxative for relief of occasional constipation
  •  
    Comfortable lubricated tip
  •  
    Works in minutes
  •  
    LATEX FREE

4.5 FL OZ (133 ml)


Advanced Ingredient Data


Raw Label Data

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