Signature Care 078.000/078aa

Signature Care 078.000/078aa
SPL v17
SPL
SPL Set ID 4947cf4d-3ebd-4b66-9582-f141407aa300
Route
ORAL
Published
Effective Date 2025-08-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Castor Oil (1 g)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-11-16

Description

Castor oil USP 100%

Purpose

Stimulant Laxative


Medication Information

Purpose

Stimulant Laxative

Description

Castor oil USP 100%

Use

For relief of occasional constipation (irregularity).  Generally produces bowel movement in 6 to 12 hours.

Warnings

for this product

Directions

Adults and children over 12 years of age - 1 to a maximum of 4 tablespoons (15 to 60 mL) in a single daily dose

children 2 to under 12 years of age - 1 to a maximum of 3 teaspoons (5 to 15 mL) in a single daily dose

children under 2 years of age - do not use, consult a doctor

Do Not Use

for a period longer than 1 week

Adverse Reaction

DISTRIBUTED BY BETTER LIVING BRANDS LLC

PO. BOX 99, PLEASANTON, CA 94566-0009

1-888-723-3929  www.betterlivingbrandsLLC.com

Active Ingredient

Castor oil USP 100%

Other Information

Keep tightly closed, away from excessive heat.

Inactive Ingredient

None

Principal Display Panel

NDC 21130-078-26

Signature Care™

Quality Guaranteed

Castor Oil U.S.P.

Stimulant Laxative

For relief of occasional constipation

Sealed with printed neckband for your protection

4 FL OZ (118 mL)

Stop Use and Ask A Doctor

if you have rectal bleeding or failure to have a bowel movement after use.  These could be signs of a serious condition.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have
  • abdominal pain, nausea, or vomiting
  • noticed a sudden change in bowel habits that persists over a period of 2 weeks
Ask A Doctor Or Pharmacist Before Use If You Are

taking any other drug.  Take this product 2 or more hours before or after other drugs.  Laxatives may affect how other drugs work.


Structured Label Content

Use

For relief of occasional constipation (irregularity).  Generally produces bowel movement in 6 to 12 hours.

Purpose

Stimulant Laxative

Warnings

for this product

Directions

Adults and children over 12 years of age - 1 to a maximum of 4 tablespoons (15 to 60 mL) in a single daily dose

children 2 to under 12 years of age - 1 to a maximum of 3 teaspoons (5 to 15 mL) in a single daily dose

children under 2 years of age - do not use, consult a doctor

Do Not Use (Do not use)

for a period longer than 1 week

Adverse Reaction (ADVERSE REACTION)

DISTRIBUTED BY BETTER LIVING BRANDS LLC

PO. BOX 99, PLEASANTON, CA 94566-0009

1-888-723-3929  www.betterlivingbrandsLLC.com

Active Ingredient (Active ingredient)

Castor oil USP 100%

Other Information (Other information)

Keep tightly closed, away from excessive heat.

Inactive Ingredient

None

Principal Display Panel (principal display panel)

NDC 21130-078-26

Signature Care™

Quality Guaranteed

Castor Oil U.S.P.

Stimulant Laxative

For relief of occasional constipation

Sealed with printed neckband for your protection

4 FL OZ (118 mL)

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if you have rectal bleeding or failure to have a bowel movement after use.  These could be signs of a serious condition.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • abdominal pain, nausea, or vomiting
  • noticed a sudden change in bowel habits that persists over a period of 2 weeks
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking any other drug.  Take this product 2 or more hours before or after other drugs.  Laxatives may affect how other drugs work.


Advanced Ingredient Data


Raw Label Data

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