LEADER CASTOR- castor oil oil

LEADER Castor by

Drug Labeling and Warnings

LEADER Castor by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Humco Holding Group, Inc.. 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. Thee 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: 1 to 4 tablesponfuls in a single daily dose or as directed by a doctor.

Children 2 to under 12 yrs. of age: 1 to 3 teaspoonfuls in a single dose or as directed by a doctor.

Children under 2 yrs. of age: Consult a doctor before use.

Other Information

storage. Keep tightly closed and away from excessive heat.

Inactive Ingredient

None

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEADER CASTOR 
castor oil oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-024
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: 37205-024-30	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/13/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	03/15/2012

Labeler - Cardinal Health (097537435)

Registrant - Humco Holding Group, Inc. (825672884)

Establishment
Name	Address	ID/FEI	Business Operations
Humco Holding Group, Inc.		825672884	manufacture(37205-024) , analysis(37205-024) , pack(37205-024) , label(37205-024)