Active Ingredient
Mineral oil 99.9%
Oil
FDA Label NDC 0869-0831
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vi-jon, Llc for the product Oil (NDC 0869-0831). 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, use, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Lubricant laxative
Use
for relief of occasional constipation (irregularity). Generally productes 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 of longer than 1 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
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 wrok.
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 signd of serious condition.
If 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 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 6 to 12 years of age - 1 to 3 teaspoons (15 mL0 in 24 hours
children under 6 years of age - do not use, consult a doctor
Other Information
keep tightly closed. Protect from sunlight.
Inactive Ingredients
mixed tocopherols (added as a stabilizer)
Other
*This product is not manufactured or distributed by Roberts Pharmaceutical Corp., distributor of Roberts Mineral Oil.
Distributed by: Vi-Jon
One Swan Drive
Smyrna, TN 37167
Alternate Principal Display Panel - Mountain Falls Brand
SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION
Mountain falls
Odorless, tasteless and colorless
For relief of occasional constipation
Lubricant laxative
Mineral oil, USP
Made in the USA with US and foreign parts
16 FL OZ (473 mL)
Principal Display Panel
NDC 0869-0831-43
Swan
MINERAL OIL U.S.P. LUBRICANT LAXATIVE
For Relief oc Occasional Constipation
Odorless, Tasteless, Colorless
COMPARE TO ACTIVE INGREDIENT OF ROBERTS MINERAL OIL
SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION
16 FL OZ (1 PT) 473 mL
Image Description (Mm1)
Image Description (Mm1)
Image Description (Mm1)
831.000/831AA
* Please review the disclaimer below.
