Indications and uses
relieves occasional constipation (irregularity) generally produces bowel movement in 6 to 8 hours
relieves occasional constipation (irregularity) generally produces bowel movement in 6 to 8 hours
do not take with meals take only at bedtime may be taken as a single daily dose or in divided doses age dose adults and children over 12 years 1 to 3 tablespoons (15 to 45 ml) maximum3 tablespoons (45mL) in 24 hours children 6 years to under 12 years 1 to 3 tablespoons (15 to 45 ml) ...
Mineral Oil
intestinal lubricant
relieves occasional constipation (irregularity)
generally produces bowel movement in 6 to 8 hours
Do not use
if you have difficulty swallowing
in children under 6 years of age
if you are pregnant
for a period longer than one week
if you are bedridden or aged
abdominal pain, nausea or vomiting
noticed a sudden change in bowel habits that persists over a period of 2 weeks
do not take with meals
take only at bedtime
rectal bleeding or failure to have a bowel movement after use
these could be signs of a serious condition
ask a health professional before use
In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately
do not take with meals
take only at bedtime
may be taken as a single daily dose or in divided doses
age dose
adults and children over 12 years 1 to 3 tablespoons (15 to 45 ml)
maximum3 tablespoons (45mL) in 24 hours
children 6 years to under 12 years 1 to 3 tablespoons (15 to 45 ml)
maximum3 tablespoons (45mL) in 24 hours
children under 6 years do not use, consult a doctorkeep tightly closed
protect from sunlight
d-alpha tocopherol (Vitamin E) as stabilizer
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0363-0360-16 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-db19-f424-e053-dadaa90a57ce | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-0360-16 | Mineral Oil | 473 mL in 1 BOTTLE, PLASTIC | OIL | 473 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| MINERAL OIL | ACTIVE INGREDIENT | T5L8T28FGP | 1 | |
| MINERAL OIL | ACTIVE MOIETY | T5L8T28FGP | 1 | |
| ALPHA-TOCOPHEROL | INACTIVE INGREDIENT | H4N855PNZ1 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0363-0360 | 0363-0360-16 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MINERAL OIL | T5L8T28FGP | ACTIB |
| ALPHA-TOCOPHEROL | H4N855PNZ1 | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | SOLUTION / ORAL | 1.05 mg/1ml | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | CAPSULE / ORAL | 16 mg | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | OINTMENT / TOPICAL | NA | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 0.64 mg | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | FILM, SOLUBLE / BUCCAL | 0.07 mg | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | TABLET, FILM COATED / ORAL | 246 mg | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | TABLET / ORAL | 2 mg | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | SYSTEM / TOPICAL | 0.1 mg | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | TABLET, CHEWABLE / ORAL | 0.1 mg | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | TABLET, EXTENDED RELEASE / ORAL | 4 mg |
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 |
|---|---|---|---|---|---|---|
| ce5ea0c1-6d8b-41a3-aac1-5d2f59cee9a1 | a39b6b6c-e2f2-4c97-bf22-8ba01e72dc03 | 2009-11-18 | Warnings | ce5ea0c1-6d8b-41a3-aac1-5d2f59cee9a1 a39b6b6c-e2f2-4c97-bf22-8ba01e72dc03 |
Adverse event summaries are temporarily unavailable. Other product information remains available.