Top Care 078.000/078aa

Top Care 078.000/078aa
SPL v27
SPL
SPL Set ID 5643f2e0-93e2-4c2e-90a0-fd152150d18a
Route
ORAL
Published
Effective Date 2025-12-11
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 1991-09-15

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 TOPCO ASSOCIATES LLC, ITASCA, IL 60143 ©TOPCO

Questions? 1-888-423-0139 [email protected] www.topcarebrand.com

Visit here for more information: http://topbrnds.com

Active Ingredient

Castor oil USP 100%

Other Information

Keep tightly closed, away from excessive heat

Inactive Ingredient

None

Principal Display Panel

TopCare ® health

NDC 36800-952-26

Castor Oil U.S.P.

Stimulant Laxative

For the Relief of Occasional Constipation

Quality Guaranteed

DO NOT USE IF SEAL UNDER CAP IS BROKEN OR MISSING.

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 TOPCO ASSOCIATES LLC, ITASCA, IL 60143 ©TOPCO

Questions? 1-888-423-0139 [email protected] www.topcarebrand.com

Visit here for more information: http://topbrnds.com

Active Ingredient (Active ingredient)

Castor oil USP 100%

Other Information (Other information)

Keep tightly closed, away from excessive heat

Inactive Ingredient (INACTIVE INGREDIENT)

None

Principal Display Panel (principal display panel)

TopCare ® health

NDC 36800-952-26

Castor Oil U.S.P.

Stimulant Laxative

For the Relief of Occasional Constipation

Quality Guaranteed

DO NOT USE IF SEAL UNDER CAP IS BROKEN OR MISSING.

4 FL OZ (118 mL)

Stop Use and Ask A Doctor If (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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