Indications and uses
relieves occasional constipation (irregularity) generally produces bowel movement in 6 to 8 hours
Mineral Oil
- Manufacturer
- Family Dollar (FAMILY WELLNESS)
- Effective date
- 2022-10-31
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:50:07
Label at a glance#
ProductMineral Oil
Active ingredientMINERAL OIL
Label structure10 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
Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Mineral Oil
Lubricant laxative
Odorless, Tasteless and Colorless
For Relief of Occasional Constipation (Irregularity)
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY: MIDWOOD BRANDS, LLC
10611 MONROE RD., MATTHEWS, NC 28105
Package Label
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55319-634-16 | 2022-10-31 | C162847 | 48780-1 | d6a99b39-6b91-a426-e053-dadaa90af4c2 | Drug Facts |
| 55319-634-16 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-6b91-a426-e053-dadaa90af4c2 | Drug Facts |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Mineral Oil
- TOCOPHEROL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55319-634 | 55319-634-16 |
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 |
|---|---|---|---|---|---|---|
| 65ef7143-a71d-400a-ae9c-6d293d22a90b | 14f40d7a-fff8-4488-93e6-9a835f1efd91 | 2022-10-31 | Warnings | 65ef7143-a71d-400a-ae9c-6d293d22a90b 14f40d7a-fff8-4488-93e6-9a835f1efd91 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.