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 adults and children 12 years of age and over: oral dosage is a minimum single dose of 15 mL to a maximum daily dose of 45 mL children 6 years to under 12 years of age: oral dosage is a minimum single dose of 5 mL to a maximum daily dose of 15 mL children under 12 years, consult a doctor
Mineral oil 100%
Lubricant laxative
you have 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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Vitamin E as stabilizer
Mineral Oil
lubricant laxative
FL OZ (mL)
Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Manufactured by:
PL Developments
513 Old Griffin Road
Piedmont, SC 29673
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49580-0334-6 | Mineral oil | 473 mL in 1 BOTTLE | OIL | 473 | 6 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49580-0334 | MINERAL OIL OIL [P & L DEVELOPMENT, LLC] | 6 | Current NDC, Legacy NDC, 1 package rows | 20250224_68e88119-1468-4ab7-a5fa-242d960d25df.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49580-0334-6 | ML - Milliliter | 49580-0334 | ee164ae0-79e5-4245-8f4f-360fe24652f2 | 1 | 2024-05-16 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| MINERAL OIL | ACTIVE INGREDIENT | T5L8T28FGP | 1 | |
| MINERAL OIL | ACTIVE MOIETY | T5L8T28FGP | 1 | |
| TOCOPHEROL | INACTIVE INGREDIENT | R0ZB2556P8 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 49580-0334 | 49580-0334-6 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MINERAL OIL | T5L8T28FGP | ACTIB |
| TOCOPHEROL | R0ZB2556P8 | 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 |
|---|---|---|---|---|---|---|
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | TABLET / ORAL | 0.08 mg | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | CAPSULE, COATED / ORAL | 0.25 mg | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | CAPSULE, COATED / ORAL | 0.25 mg | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | TABLET / ORAL | 0.08 mg | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | CAPSULE / ORAL | NA | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | CAPSULE / ORAL | NA |
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 |
|---|---|---|---|---|---|---|
| Mineral oil | MINERAL OIL | P & L Development, LLC | 68e88119-1468-4ab7-a5fa-242d960d25df | 2025-02-21 | Warnings | 49580-0334-6 49580-0334 49580033406 6651c0e4-d583-401d-96c4-5cb5fe10bd97 68e88119-1468-4ab7-a5fa-242d960d25df |
Adverse event summaries are temporarily unavailable. Other product information remains available.