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NDC 37205-0024-30 LEADER Castor 1 mg/mL Details

LEADER Castor 1 mg/mL

LEADER Castor is a ORAL OIL in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health. The primary component is CASTOR OIL.

Product Information

NDC	37205-0024
Product ID	37205-024_e42a41ce-14a2-6abb-e053-2a95a90a9216
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	LEADER Castor
Proprietary Name Suffix	n/a
Non-Proprietary Name	Castor Oil
Product Type	HUMAN OTC DRUG
Dosage Form	OIL
Route	ORAL
Active Ingredient Strength	1
Active Ingredient Units	mg/mL
Substance Name	CASTOR OIL
Labeler Name	Cardinal Health
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	n/a

Package

Package Images

NDC 37205-0024-30 (37205002430)

Pricing Information	N/A
NDC Package Code	37205-024-30
Billing NDC	37205002430
Package	177 mL in 1 BOTTLE (37205-024-30)
Marketing Start Date	2017-12-13
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6cbd72cf-85c4-45c6-ad7b-2d4cc32420f4 Details

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

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37205-024-30	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/13/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	03/15/2012	02/29/2024

Labeler - Cardinal Health (097537435)

Registrant - Humco Holding Group, Inc. (825672884)

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

Revised: 7/2022

Document Id: e42a41ce-14a2-6abb-e053-2a95a90a9216

Set id: 6cbd72cf-85c4-45c6-ad7b-2d4cc32420f4

Version: 4

Effective Time: 20220719