FDA Label for Mineral Oil
View Indications, Usage & Precautions
Mineral Oil Product Label
The following document was submitted to the FDA by the labeler of this product Geritrex Llc. 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.
Active Ingredient
Mineral Oil 99.99%
Purpose:
Lubricant Laxative
Uses
For relief of occasional constipation (irregularity)
generally produces bowel movement in 6 to 8 hours
Warnings
Do not use
- if you have difficulty swallowing
- in children under 6 years of age
- if you are pregnant
- for a period longer than one week
- if you are bedridden or aged
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
- Presently taking a stool softener laxative
- Taking any other drug
- Take this product 2 or more hours before or after drugs
- Laxatives may affect how other drugs work
Ask a doctor of pharmamcist before use if you are
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 The Reach Of Children
In case of accidental 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 daily dose or in divided doses
Age Dose
adults and children over 12 years 1 to 3 tablespoons (15 to 45 ml)
maximum 3 tablespoons (45mL) in 24 hours
children 6 years to under 12 years 1 to 3 teaspoons(15 to 45 ml)
maximum 3 teaspoons (45mL) in 24 hours
Children under 6 years Do not use, consult a doctor
Other Information
Keep tightly closed. Protect from sunlight. For more info call 800-736-3437
Inactive Ingredients
Mixed tocopherols (added as a stabilizer)
Principal Display Panel
Geritrex
Mineral Oil
USP
Lubricant Laxative
Odorless
Tasteless
Colorless
16 OZ (472 ml)
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