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Drug Facts
Freskaro Castor Oil Liquid
FDA Label NDC 82645-515
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharma Nobis, Llc for the product Freskaro Castor Oil (NDC 82645-515). 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 other, active ingredient, purpose, use, warings, ask a doctor before use, when using this product, 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
Active Ingredient
Castor Oil
Purpose
Stimulant Laxative
Use
For the temporary relief of occasional constipation. Bowel movement is generally produced in 6 to 12 hours.
Warings
Do not use when abdominal pain, nausea, or vomiting are present unless directed by a doctor.
Ask A Doctor Before Use
if you have noticed a sudden change in bowel habits that persists over a period of 2 weeks. Laxative products should not be used for a period of longer than 1 week unless directed by a doctor. Frequent or prolonged use may result in the dependence on laxatives.
When Using This Product
Discontinue use and consult a doctor if you have rectal bleeding or failure to have a bowel movement after the use of a laxative. These symptoms may indicate a serious condition.
If Pregnant Or Breast Feeding
ask a health professional before use
Keep Out Of Reach Of Children.
In case of accidental overdose, seek profssional assistance or contact a Poison Control Center immediately.
Directions
Preferably take on an empty stomach. May be taken with juice to improve taste.
Adults and children 12 yrs. of age and older: 15 to 60 milliliters in a single daily dose or as directed by a doctor.
Children 2 to under 12 yrs. of age: 5 to 15 milliliters in a single dose or as directed by a doctor.
Children under 2 yrs. of age: Consult a doctor before use.
Warnings:
Do not use if Taper Evident Seal is broken or missing. This product is sealed with either a shrink band around cap imprinted "Sealed For your Protection" or foil seal under cap.
Other Information
storage. Keep tightly closed and away from excessive heat.
Inactive Ingredient
None
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