Indications and uses
for relief of occasional constipation
Mineral Oil Lubricant Laxative
- Manufacturer
- McKesson
- Effective date
- 2012-11-27
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 22:33:49
Label at a glance#
ProductMineral Oil Lubricant Laxative
Active ingredientMINERAL OIL
Label structure10 sections
Dosage and administration
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...
Storage and handling
store at room temperature 20-25 deg C (68-77 deg F) this product generally produces bowel movement in 2-15 minutes
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient
(in each 118 mL delivered dose)
Mineral oil 100%
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
If pregnant or breastfeeding, ask a health professional before use.
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.
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.
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
NDC 49348-006-11
Complete
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)
Side and Back Panel - Box
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49348-006-11 | 2019-11-27 | C162847 | 48780-1 | 9855d018-ef1e-cd31-e053-dbdaa90ab51a | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49348-006-11 | Mineral Oil Lubricant Laxative | 133 mL in 1 BOTTLE | ENEMA | 133 | 3 | |
| 49348-006-11 | Mineral Oil Lubricant Laxative | 1 in 1 BOX | ENEMA | 1 | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| MINERAL OIL | ACTIVE INGREDIENT | T5L8T28FGP | 3 | |
| MINERAL OIL | ACTIVE MOIETY | T5L8T28FGP | 3 |
Products#
Every source-derived product name is available through these pages.
- Mineral Oil Lubricant Laxative
- mineral oil
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 49348-006 | 49348-006-11 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MINERAL OIL | T5L8T28FGP | ACTIB |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| c58744ba-2de1-4157-a0eb-78f89239c4fc | 147f6203-0abf-4113-b3ea-3512e5ccae15 | 2012-11-27 | Warnings | c58744ba-2de1-4157-a0eb-78f89239c4fc 147f6203-0abf-4113-b3ea-3512e5ccae15 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.