Active Ingredient
Mineral oil 99.9%
Mineral Oil Liquid
FDA Label NDC 50804-831
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Perrigo Direct, Inc for the product Mineral Oil (NDC 50804-831). 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, do not use, 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 produces bowel movement in 6 to 8 hours
Do Not Use
- if you have difficulty swallowing
- in children under 6 years of age
- if you are pregnant
- for a period 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 work
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 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 - 45 mL) maximum 3 Tablespoons (45 mL) in 24 hours
children 6 to under 12 years of age - 1 to 3 teaspoons (5 - 15 mL) maximum 3 teaspoons (15 mL) 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)
Disclaimer
This product is not manufactured or distributed by Roberts Pharmaceutical Corp., distibutor of Roberts Mineral Oil
Adverse Reactions
Distributed By: Geiss, Destin & Dunn, Inc
Peachtree City, GA 30269
www.valuelabels.com
831.000/831AA
Principal Display Panel
NDC 50804-831-43
GoodSense
SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION
Mineral Oil USP
Lubricant Laxative
For relief of occasional constipatio
ODORLESS - TASTELESS - COLORLESS
100%
SATISFACTION
GUARANTEED
Compare to active ingredient of
Roberts Mineral Oil
16 FL OZ (1 PT) 473 mL
Made in the USA with US and foreign components
Image Description (Mm1)
Image Description (Mm1)
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