Swan 078.000/078aa

Swan 078.000/078aa
SPL v18
SPL
SPL Set ID b29775df-8470-4fe3-bee3-f0490ea6903f
Route
ORAL
Published
Effective Date 2024-03-26
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 1989-07-15 Until 2025-04-08

Description

Distributed by: Vi-Jon, INC., One Swan Drive, Smyrna, TN 37167

Purpose

Stimulant laxative


Medication Information

Purpose

Stimulant laxative

Description

Distributed by: Vi-Jon, INC., One Swan Drive, Smyrna, TN 37167

Use

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

Section 42229-5

Distributed by: Vi-Jon, INC.,

One Swan Drive, Smyrna, TN 37167

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

Active Ingredient

Castor Oil USP 100%

Other Information

keep tightly closed, away from excessive heat

Inactive Ingredient

None

Principal Display Panel

NDC 0869-0078-26

Swan

Caster Oil

U.S.P. STIMULANT LAXATIVE

For the Relief of Occasional Constipation

DO NOT USE IF PRINTED NECKBAND IS BROKWN OR MISSING.

4FL OZ (118mL)

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.

Section 42229-5 (42229-5)

Distributed by: Vi-Jon, INC.,

One Swan Drive, Smyrna, TN 37167

Purpose

Stimulant laxative

Warnings (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

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 0869-0078-26

Swan

Caster Oil

U.S.P. STIMULANT LAXATIVE

For the Relief of Occasional Constipation

DO NOT USE IF PRINTED NECKBAND IS BROKWN OR MISSING.

4FL OZ (118mL)

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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