Active Ingredient
Mineral Oil 100%
Mineral Oil
FDA Label NDC 46122-395
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amerisourcebergen (good Neighbor Pharmacy) 46122 for the product Mineral Oil (NDC 46122-395). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if you have, if pregnant or breast feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Questions or Concerns? Visit us at www.mygnp.com
Questions or comments? Call 1-877-753-3935
Monday-Friday 9AM-5PM EST
Package Label
Mineral Oil 100% (Mineral Oil 1)
* Please review the disclaimer below.
