Active Ingredient
(in each 118 mL delivered dose)
Mineral oil 100%
Mineral Oil Lubricant Laxative
FDA Label NDC 49348-006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mckesson for the product Mineral Oil Lubricant Laxative (NDC 49348-006). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, ask a doctor before use if you have, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Lubricant laxative
Uses
- for relief of occasional constipation
Warnings
For rectal use only
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
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)
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.
Remove Protective Shield Illustration (C58744ba 2de1 4157 A0eb 78f89239c4fc 01)
Positioning:
Left-side position: Lie on left side with knee bent and arms at rest.
Left Side Position Illustration (C58744ba 2de1 4157 A0eb 78f89239c4fc 02)
Knee-chest position:
Kneel, then lower head and chest forward until left side of face is resting on surface. Position arms comfortably.
Knee-chest Position Illustration (C58744ba 2de1 4157 A0eb 78f89239c4fc 03)
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.
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 Principal Display Panel - Box
Sunmark Mineral Oil Enema Box Principal Display Panel (C58744ba 2de1 4157 A0eb 78f89239c4fc 04)
Sunmark
NDC 49348-006-11
Complete
Ready-to-use
Enema
Mineral Oil
4.5 FL OZ (133 ml)
* Please review the disclaimer below.
