Active Ingredient
Mineral oil 100%
Mineral Oil
FDA Label NDC 49580-0334
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by P & L Development, Llc for the product Mineral Oil (NDC 49580-0334). 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, 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 women, 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 ingestion, 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 Ingredients
Vitamin E as stabilizer
Principal Display Panel
Mineral Oil
lubricant laxative
- odorless
- tasteless
- colorless
FL OZ (mL)
Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM ESTÂ
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Manufactured by:
PL Developments
1874 Hwy 72 W,
Clinton, SC 29325
Package Label
ReadyinCase Mineral Oil
* Please review the disclaimer below.
