Indications and uses
relieves occasional constipation (irregularity) generally produces bowel movement in 6 to 8 hours
Mineral Oil
- Manufacturer
- Care One (American Sales Company)
- Effective date
- 2022-11-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:47:17
Label at a glance#
ProductMineral Oil
Active ingredientMINERAL OIL
Label structure9 sections
Dosage and administration
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 1 to 3 tablespoons (15 to 45 mL) maximum 3 tablespoons (45 mL) in 24 hours children under 12 years, consult a doctor
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredient
Mineral Oil 100%
Purpose
Lubricant laxative
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 6 to 8 hours
Warnings
Do not use
- in children under 12 years of age, pregnant wormen, bedridden patients or aged, or if you have difficulty swallowing
- if you are presently taking a stool softener laxative
- for longer than 1 week
Ask a doctor before use if you have
- abdominal pain, nausea or vomiting
- noticed a sudden change in bowel habits that persists over a period of 2 weeks
When using this product
- do not take with meals
- take only at bedtime
Stop use and ask a doctor if you have
rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.
If pregnant or breast feeding,
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 (1-800-222-1222) right away.
Directions
- 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
- 1 to 3 tablespoons (15 to 45 mL)
- maximum 3 tablespoons (45 mL) in 24 hours
- children under 12 years, consult a doctor
Other Information
- keep tightly closed
- protect from direct light
Inactive Ingredient
Vitamin E as stabilizer
Principal Display Panel
MINERAL OIL
Lubricant Laxative
ODORLESS, TASTELESS, COLORLESS
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY
FOODHOLD U.S.A., LLC
LANDOVER, MD 20785
1-877-846-9949 •©2016 S&S Brands,LLC
Questions or comment?
Call 1-877-753-3935 Monday-Friday 9am-5pm EST
Package Label
Products#
Every source-derived product name is available through these pages.
- Mineral Oil
- TOCOPHEROL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 41520-334 | 41520-334-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MINERAL OIL | T5L8T28FGP | ACTIB |
| TOCOPHEROL | R0ZB2556P8 | IACT |
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 |
|---|---|---|---|---|---|---|
| b6ca4adf-b868-4822-8e37-3f532726aa09 | 33ebb291-74a2-40a8-aada-6c422e63e757 | 2022-11-21 | Warnings | b6ca4adf-b868-4822-8e37-3f532726aa09 33ebb291-74a2-40a8-aada-6c422e63e757 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.