FRESKARO CASTOR OIL- castor oil liquid

Freskaro Castor Oil by

Drug Labeling and Warnings

Freskaro Castor Oil by is a Otc medication manufactured, distributed, or labeled by Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FRESKARO CASTOR OIL 
castor oil liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82645-515
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CASTOR OIL (UNII: D5340Y2I9G) (CASTOR OIL - UNII:D5340Y2I9G)	CASTOR OIL	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82645-515-96	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/16/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	05/16/2023

Labeler - Pharma Nobis, LLC (118564114)

Registrant - Pharma Nobis, LLC (118564114)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Nobis, LLC		118564114	manufacture(82645-515) , analysis(82645-515) , pack(82645-515) , label(82645-515)