Dosage and administration
Adults and children 12 yrs and older: 1 to 2 tablespoonfulls at bedtime. Children 6 to 12 yrs. of age: 1 to 3 teaspoonfuls at bedtime. Children under 6 yrs. of age: Consult a doctor before use.
Mineral Oil Heavy
- Manufacturer
- Humco Holding Group, Inc.
- Effective date
- 2020-06-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:18:49
Label at a glance#
ProductMineral Oil Heavy
Active ingredientMINERAL OIL
Label structure13 sections
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient
Mineral Oil Heavy
Purpose
Laxative
Use
For relief of occasional constipation or irregularit. Generally produces bowel movement in 6 to 8 hrs.
Warnings
Do not take this product if you have abdominal pain, nausea, vomiting, change in bowel habits persisting more than 2 weeks, rectal bleeding or kidney failure are present, or use for a period of longer than 1 week unless directed by a doctor. Frequent or prolonged use may result in the dependence on laxatives.
Do not administer to infants or young children, bedridden or aged patients unless directed by a doctor.
Ask a doctor before use if
you are currently taking a stool softener laxative.
If pregnant or brest feeding ask a health professional before use.
When using this Product discotinue use
and consult a doctor if there is a failure to have a bowel movement after use.
Keep out of reach of children
In case of accidental overdose, seek professional assistance or contact Poison Control Center immediately. In case of eye contact wash gently with water for 15 minutes.
Directions
Adults and children 12 yrs and older: 1 to 2 tablespoonfulls at bedtime.
Children 6 to 12 yrs. of age: 1 to 3 teaspoonfuls at bedtime.
Children under 6 yrs. of age: Consult a doctor before use.
Inactive ingredient
dl-alpha-tocopherol as a preservative.
Other information
Keep tightly closed and protect from direct light.
CVS Label
Leader Label
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0395-9135-16 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-ab35-d8a0-e053-dadaa90a6e4e | Private Label Mineral Oil Heavy |
| 0395-9135-32 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-ab35-d8a0-e053-dadaa90a6e4e | Private Label Mineral Oil Heavy |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0395-9135-16 | Mineral Oil Heavy | 473 mL in 1 BOTTLE, PLASTIC | LIQUID | 473 | 1 | |
| 0395-9135-32 | Mineral Oil Heavy | 950 mL in 1 BOTTLE, PLASTIC | LIQUID | 950 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Mineral Oil Heavy
- Mineral Oil
- .ALPHA.-TOCOPHEROL ACETATE, DL-
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0395-9135 | 0395-9135-16, 0395-9135-32 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| .ALPHA.-TOCOPHEROL ACETATE, DL- | WR1WPI7EW8 | IACT |
| 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 |
|---|---|---|---|---|---|---|
| a8c1f436-e5de-0cc0-e053-2a95a90a2d16 | a8c1f436-e5dd-0cc0-e053-2a95a90a2d16 | 2020-06-23 | Warnings | a8c1f436-e5de-0cc0-e053-2a95a90a2d16 a8c1f436-e5dd-0cc0-e053-2a95a90a2d16 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.