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 Amerisourcebergen (good Neighbor Pharmacy) 46122. 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 100%
Purpose
Lubricant laxative
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 6 to 8 hours
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
SAFETY SEALED
Mineral Oil USP
Lubricant Laxative
Odorless-Tasteless
Crystal Clear
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Distributed by AmerisourceBergen
1300 Morris Drive, Chesterbrook, PA 19087
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Package Label
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