Active Ingredient
Mineral Oil
Mineral Oil
FDA Label NDC 0363-0360
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Mineral Oil (NDC 0363-0360). 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, uses, warnings, 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,, keep this and all drugs out of the reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
relieves occasional constipation (irregularity)
generally produces 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 longer than one 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
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 This And All Drugs Out Of The Reach Of Children
In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately
Directions
do not take with meals
take only at bedtime
may be taken as a single daily dose or in divided doses
age dose
adults and children over 12 years 1 to 3 tablespoons (15 to 45 ml)
maximum3 tablespoons (45mL) in 24 hours
children 6 years to under 12 years 1 to 3 tablespoons (15 to 45 ml)
maximum3 tablespoons (45mL) in 24 hours
children under 6 years do not use, consult a doctorOther Information
keep tightly closed
protect from sunlight
Inactive Ingredient
d-alpha tocopherol (Vitamin E) as stabilizer
Principal Display Panel
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