Indications and uses
• for relief of occasional constipation
Sunmark Mineral Oil
- Manufacturer
- Mckesson Corporation
- Effective date
- 2015-07-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 22:43:06
Label at a glance#
ProductSunmark Mineral Oil
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 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. Positioning: Left-side position: Lie on l...
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 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.
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
Principal Display Panel
Sunmark
Compare to Fleet® Mineral Oil Enema active ingredient
NDC 49348-880-20
Complete Ready-To-Use
Enema
Mineral Oil
Sodium Free Lubricant
Laxative For Relief
of Occasional Constipation
Comfortable, Lubricated Tip
Latex Free
4.5 FL OZ (133ml)
Side and Back Panel - Box
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49348-880-20 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-21a5-f424-e053-dadaa90a57ce | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49348-880-20 | Sunmark Mineral Oil | 133 mL in 1 BOTTLE | ENEMA | 133 | 3 | |
| 49348-880-20 | Sunmark Mineral Oil | 1 in 1 BOX | ENEMA | 1 | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49348-880-20 | ML - Milliliter | 49348-880 | ae70c78c-09f5-47cf-ba93-aedf6e56e984 | 1 | 2015-02-02 |
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.
- Sunmark Mineral Oil
- Mineral Oil
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 49348-880 | 49348-880-20 |
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 |
|---|---|---|---|---|---|---|
| 925963ca-3b24-4400-9650-839358e8ada7 | e72a48cd-e9cc-47e3-99ed-73440803ad28 | 2015-07-14 | Warnings | 925963ca-3b24-4400-9650-839358e8ada7 e72a48cd-e9cc-47e3-99ed-73440803ad28 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.