PSP CASTOR STIMULANT LAXATIVE- castor oil oil
RW Consumer Products Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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PSP Castor Oil USP Stimulant Laxative

Drug Facts

Active ingredient

Castor Oil 100%

Purpose

Stimulant laxative

Use

for the temporary relief of occasional constipation.
bowel movement is generally produced in 2 to 6 hours.

Warnings

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 persist 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 indicate a serious condition.

If pregnant or breast feeding consult a health professional before use.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Directions

Take once a day in the morning on an empty stomach.

• Adults and children 12 yrs. of age and older:
1 to 4 tablespoons (15 to 60ml) in a single daily dose or as directed by a doctor.
• Children 2 to under 12 yrs. of age:
1 to 3 teaspoons (5 to 15ml) in a single daily 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.
Do not use if induction seal under cap is broken or missing

Inactive ingredients:

None

Package Labeling:

Label

PSP CASTOR STIMULANT LAXATIVE
castor oil oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69612-017
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 g in 1 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69612-017-01	1 in 1 BOX	10/01/2021	05/20/2022
1		100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	10/01/2021	05/20/2022

Labeler - RW Consumer Products Ltd (245592118)

Revised: 5/2022

Document Id: df741f0d-4239-900f-e053-2995a90aae61

Set id: cbe55082-3a90-3997-e053-2a95a90a8e8e

Version: 2

Effective Time: 20220520

RW Consumer Products Ltd