SPL v3
SPL
SPL Set ID 7b9b0e4b-0511-414e-9163-c5317474cf18
Route
RECTAL
Published
Effective Date 2013-05-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Mineral Oil (113.115 g)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-05-10

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

Discard unused portion

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.

 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.

 

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.

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

Back & Side Panel Box
Principal Display Panel

NDC 41250-112-11

Compare to Fleet® Mineral Oil Enema active ingredient*

Meijer

Ready-To-Use

Enema Mineral Oil

Sodium Free

Lubricant Laxative

For Relief of

Occasional Constipation

Latex Free

Protective Shield prevents contamination

Safety Seal for added protection

Comfortable, lubricated tip for insertion

One-way safety valve controls flow and prevents reflux

Easy, soft squeeze bottle

4.5 FL OZ (133ml)

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

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

Discard unused portion

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.

 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.

 

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.

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

Back & Side Panel Box (Back & Side Panel - Box)
Principal Display Panel

NDC 41250-112-11

Compare to Fleet® Mineral Oil Enema active ingredient*

Meijer

Ready-To-Use

Enema Mineral Oil

Sodium Free

Lubricant Laxative

For Relief of

Occasional Constipation

Latex Free

Protective Shield prevents contamination

Safety Seal for added protection

Comfortable, lubricated tip for insertion

One-way safety valve controls flow and prevents reflux

Easy, soft squeeze bottle

4.5 FL OZ (133ml)

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

Advanced Ingredient Data


Raw Label Data

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