Otc - Active Ingredient
Mineral Oil
Leader Mineral Oil Liquid
FDA Label NDC 70000-0448
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health, 110 Dba Leader for the product Leader Mineral Oil (NDC 70000-0448). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - keep out of reach of children, otc - stop use, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Lubricant Laxative
Indications & Usage
For relief of occasional constpation or irregularity. Generally produces bowel movement in 6 to 8 hours.
Warnings
Do not use if you have difficulty swallowing, in children under 12 years of age, if you are pregnant, for a period longer than 1 week, if you are bedridden or aged, if you are presently taking a stool softener laxative
Otc - Ask Doctor
Ask a doctor before usage if you hav abdominal pain, nausea, or vomiting, noticed a sudden change in bowel habits that persists over a period of 2 weeks.
Otc - Keep Out Of Reach Of Children
In case of accidental overdose, seek professional assistance or contact Poison Control Center immediately. In case of eye contact wash gently with water for 15 minutes.
Otc - Stop Use
and consult a doctor if there is a fialure to have a bowel movement after use.
Dosage & Administration
Adults and children 12 yrs and older: 1 to 2 tablespoonfulls at bedtime.
Children 6 to 12 yes of age: 1 to 3 teaspoonfulls at bedtime.
Children under 6 yrs of age: Consult a doctor before use
Inactive Ingredient
dl-alpha-tocopherol as a preservative
Other Safety Information
Keep tightly closed and protected from direct light
Package Label.Principal Display Panel
Mineraloil (Mineraloil)
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