7b9b0e4b-0511-414e-9163-c5317474cf18

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

Purpose

Lubricant laxative

Description

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


Medication Information

Warnings

For rectal use only

Uses
  • for relief of occasional constipation
Purpose

Lubricant laxative

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.

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

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

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)

Active Ingredient

(in each 118 mL delivered dose)

Mineral oil 100%

Inactive Ingredient

none

Questions Or Comments?

1-800-633-5463

Back & Side 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

Structured Label Content

Warnings

For rectal use only

Uses
  • for relief of occasional constipation
Purpose

Lubricant laxative

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.

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

Active Ingredient (Active ingredient)

(in each 118 mL delivered dose)

Mineral oil 100%

Inactive Ingredient (Inactive ingredient)

none

Questions Or Comments? (Questions or comments?)

1-800-633-5463

Back & Side Panel Box (Back & Side 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

Advanced Ingredient Data


Raw Label Data

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