Freskaro Castor Oil

Manufacturer
Pharma Nobis, LLC
Effective date
2023-12-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:05:56

Label at a glance#

ProductFreskaro Castor Oil
Active ingredientCASTOR OIL
Label structure14 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Castor Oil

Purpose

OTC - PURPOSE SECTION

Stimulant Laxative

Use

INDICATIONS & USAGE SECTION

For the temporary relief of occasional constipation. Bowel movement is generally produced in 6 to 12 hours.

Warings

WARNINGS SECTION

Do not use when abdominal pain, nausea, or vomiting are present unless directed by a doctor.

Ask a doctor before use

OTC - ASK DOCTOR SECTION

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

OTC - WHEN USING SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, seek profssional assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

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:

WARNINGS SECTION

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

SPL UNCLASSIFIED SECTION

storage. Keep tightly closed and away from excessive heat.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

None

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Freskaro Castor Oil 5-16-23Freskaro Castor Oil 5-16-23

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82645-515-96Freskaro Castor Oil177 mL in 1 BOTTLE, PLASTICLIQUID1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82645-515FRESKARO CASTOR OIL (CASTOR OIL) LIQUID [PHARMA NOBIS, LLC]2Current NDC, 1 package rows20231229_fbd6bdd5-a7a1-3f28-e053-6294a90aab87.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82645-51582645-515-96

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CASTOR OILD5340Y2I9GACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Freskaro Castor OilCASTOR OILPharma Nobis, LLCfbd6bdd5-a7a1-3f28-e053-6294a90aab872023-12-28WarningsExact identifier
ndc (package): 82645-515-96
ndc (product): 82645-515
ndc11 (package): 82645051596
spl id: 0d99cc17-4c17-6458-e063-6394a90a02c1
spl set id: fbd6bdd5-a7a1-3f28-e053-6294a90aab87

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.