Mineral Oil
- Manufacturer
- Blossom Pharmaceuticals
- Effective date
- 2014-01-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:38:18
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredient Purpose
Mineral Oil, 100% Lubricant Laxative
Purpose
- Gentle relief of occasional constipation
Warnings:
For rectal use only
As 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
- If pregnant or breast feeding, ask a health professional before use.
Indications & Usage
- If you have rectal bleeding or failure to have a bowel movement after use of a laxative because this amy 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
If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Other information:
- Store at room temperature 20 Deg C - 25 Deg C (68 Deg F - 77 Deg F)
- This product produces bowel movement in 2 to 15 minutes
Dosage & Administration
Single daily dose
Adults and children 12 years and older - 1 bottle
Children 2 to under 12 years - 1/2 bottle
Children under 2 years - Do not use. Consult a physician.
How to use this enema:
REMOVE GREEN PROTECTIVE SHIELD BEFORE INSERTING.
Hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with the other hand and pull gently to remove.
See image on box
Positioning
Left-side position: Lie on left side with knee bent and arms at rest.
See image on box
Knee-chest position: Kneel, then lower head and chest forward until the left side of face is resting on surface. Position arms comfortably.
See image on box
Administering Enema
- With steady pressure, gently insert enema with tip pointing toward navel.
Squeeze bottle until recommended dose is expelled (it is not necessary to
empty unit completely. Bottle contains more liquid than needed for effective
use. A small amount of liquid will remain in bottle after squeezing).
Remove tip from rectum.
Stop using if tip is hard to insert. Forcing the tip into the rectum can
cause injury (especially if you have hemorrhoids). If enema tip causes
rectal bleeding or pain, get immediatemedical care.
Maintain position until urge to evacuate is strong (usually 1 to 5 minutes).
If no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor
promptly if no liquid comes out of the rectum after 30 minutes because
dehydration could occur.
Principal Display Panel
Mineral oil enema.jpg
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61767-001-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-1e13-f424-e053-dadaa90a57ce | Enema, Mineral Oil |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61767-001-01 | Mineral Oil | 1 in 1 BOX | ENEMA | 1 | 1 | |
| 61767-001-01 | Mineral Oil | 118 mL in 1 BOTTLE | ENEMA | 118 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| MINERAL OIL | ACTIVE INGREDIENT | T5L8T28FGP | 1 | |
| MINERAL OIL | ACTIVE MOIETY | T5L8T28FGP | 1 |
Products#
Every source-derived product name is available through these pages.
- Mineral Oil
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61767-001 | 61767-001-01 |
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 |
|---|---|---|---|---|---|---|
| 8f1f9218-cdf8-4217-af36-2269f532b7fe | e0d31f14-5e11-4370-b0c6-adb639db164c | 2014-01-29 | Warnings | 8f1f9218-cdf8-4217-af36-2269f532b7fe e0d31f14-5e11-4370-b0c6-adb639db164c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
