FDA Label for Mineral Oil
View Indications, Usage & Precautions
- DRUG FACTS
- INACTIVE INGREDIENT
- PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE
- ASK A DOCTOR OR PHARMACIST BEFORE USE
- WHEN USING
- STOP USE AND ASK A DOCTOR
- IF PREGNANT OR BREASTFEEDING
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- QUESTIONS OR COMMENTS ?
- OTHER
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Mineral Oil Product Label
The following document was submitted to the FDA by the labeler of this product Kesin Pharma Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Active Ingredient
Mineral Oil (100%)
Lubricant Laxative
Inactive Ingredient
There are no other inactive ingredients.
Purpose
Lubricant Laxative
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 6 to 8 hours
Do Not Use
Do not use
- if you have difficulty swallowing
- in children under 6 years of age
- if you are pregnant
- for a period longer than 1 week
- if you are bedridden or aged
Ask A Doctor Before Use
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
Ask A Doctor Or Pharmacist Before Use
Ask a doctor or pharmacist before use if you are
- presently taking a stool softener laxative
- taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.
When Using
When using this product
- do not take with meals
- take only at bedtime
Stop Use And Ask A Doctor
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 Breastfeeding
If pregnant or breastfeeding, ask a health professional before use.
Keep Out Of Reach Of Children.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not take with meals
- take only at bedtime
- may be taken as a single dose or as directed by a doctor
| Age | Dose |
| adults and children 12 years of age and over | 1 to 3 Tablespoons (15 mL to 45 mL)
maximum 3 Tablespoons (45 mL) in 24 hours |
| children 6 to under 12 years of age | 1 to 3 teaspoons (5 mL to 15 mL)
maximum 3 teaspoons (15 mL) in 24 hours |
| children under 6 years | do not use. consult a doctor. |
Other Information
- store at 20°C to 25°C (68°F to 77°F)
- protect from direct light
- NDC 81033-042-30: 30 mL unit dose cup
- NDC 81033-042-50: Carton containing 50 - 30 mL unit dose cups
Questions Or Comments ?
Call 1-833-537-4679
Other
Packaged by:
Kesin Pharma
Oldsmar, FL 34677
Rev. 03/2025
Package Label.Principal Display Panel
NDC 81033-042-50
Mineral Oil, USP 30 mL
Delivers 30 mL
FOR INSTITUTIONAL ONLY
50 x 30 mL Unit Dose Cups
Store at 68°F to 77°F (20°C to 25°C)
* Please review the disclaimer below.
