Drug Facts

Composition & Product

Active Ingredients

Docusate (250 mg)

Inactive Ingredients

Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycols Propylene Glycol Water Sorbitol

Identifiers & Packaging

Pill Appearance

Imprint: P20 Shape: oval Color: orange Size: 20 mm Score: 1

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2014-01-01

Medication Information

Purpose

Stool softener

Description

Docusate Sodium 250 mg

Uses

for the prevention of dry, hard stools
for relief of occasional constipation
this product generally produces a bowel movement within 12 to 72 hours

Directions

adults and children 12 years of age and over: take1 softgel daily or as directed by a doctor
children under 12 years of age: take as directed by a doctor

Do Not Use

if you are currently taking mineral oil, unless directed by a doctor
when abdominal pain, nausea, or vomiting are present
for more than 1 week, unless directed by a doctor

Package Label

Label Image for 53808-0902

250mg

Other Information

each softgel contains: sodium 15 mg
store between 15º-30ºC (59º-86ºF)

Inactive Ingredients

edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special

Questions Or Comments?

1-800-645-2158

Distributed by: Rugby Laboratories

31778 Enterprise Drive

Livonia, MI 48150

www.rugbylaboratories.com

This Product was Repackaged By:

State of Florida DOH Central Pharmacy

104-2 Hamilton Park Drive

Tallahassee, FL 32304

USA

And supplied by State of Florida DOH Central Pharmacy as follows:

NDC	Strength	Quantity/Form	Color	Source Prod. Code
53808-0902-1	250 MG	30 Capsules in a Blister Pack	orange	0536-3757

Ask A Doctor Before Use If

you notice a sudden change in bowel habits that persists over a period of 2 weeks.

Stop Use and Ask A Doctor If

you have rectal bleeding
you fail 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.

Active Ingredient (in Each Softgel)

Docusate Sodium 250 mg

Structured Label Content

Uses

for the prevention of dry, hard stools
for relief of occasional constipation
this product generally produces a bowel movement within 12 to 72 hours

Purpose

Stool softener

Directions

adults and children 12 years of age and over: take1 softgel daily or as directed by a doctor
children under 12 years of age: take as directed by a doctor

Do Not Use (Do not use)

if you are currently taking mineral oil, unless directed by a doctor
when abdominal pain, nausea, or vomiting are present
for more than 1 week, unless directed by a doctor

Package Label (PACKAGE LABEL)

Label Image for 53808-0902

250mg

Other Information (Other information)

each softgel contains: sodium 15 mg
store between 15º-30ºC (59º-86ºF)

Inactive Ingredients

edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special

Questions Or Comments? (Questions or comments?)

1-800-645-2158

Distributed by: Rugby Laboratories

31778 Enterprise Drive

Livonia, MI 48150

www.rugbylaboratories.com

This Product was Repackaged By:

State of Florida DOH Central Pharmacy

104-2 Hamilton Park Drive

Tallahassee, FL 32304

USA

And supplied by State of Florida DOH Central Pharmacy as follows:

NDC	Strength	Quantity/Form	Color	Source Prod. Code
53808-0902-1	250 MG	30 Capsules in a Blister Pack	orange	0536-3757

Ask A Doctor Before Use If (Ask a doctor before use if)

you notice a sudden change in bowel habits that persists over a period of 2 weeks.

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

you have rectal bleeding
you fail 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.

Active Ingredient (in Each Softgel) (Active Ingredient (in each softgel))

Docusate Sodium 250 mg

Advanced Ingredient Data

[{"name": "DOCUSATE", "unii": "M7P27195AG", "classCode": "ACTIB", "strengthNumerator": "250", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOLS", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "for the prevention of dry, hard stools for relief of occasional constipation this product generally produces a bowel movement within 12 to 72 hours", "Purpose": "Stool softener", "Directions": "adults and children 12 years of age and over: take1 softgel daily or as directed by a doctor children under 12 years of age : take as directed by a doctor", "Do not use": "if you are currently taking mineral oil, unless directed by a doctor when abdominal pain, nausea, or vomiting are present for more than 1 week, unless directed by a doctor", "PACKAGE LABEL": "Label Image for 53808-0902 250mg", "Other information": "each softgel contains: sodium 15 mg store between 15º-30ºC (59º-86ºF)", "Inactive Ingredients": "edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special", "Questions or comments?": "1-800-645-2158 Distributed by: Rugby Laboratories 31778 Enterprise Drive Livonia, MI 48150 www.rugbylaboratories.com This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 USA And supplied by State of Florida DOH Central Pharmacy as follows: NDC Strength Quantity/Form Color Source Prod. Code 53808-0902-1 250 MG 30 Capsules in a Blister Pack orange 0536-3757", "Ask a doctor before use if": "you notice a sudden change in bowel habits that persists over a period of 2 weeks.", "Stop use and ask a doctor if": "you have rectal bleeding you fail 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.", "Active Ingredient (in each softgel)": "Docusate Sodium 250 mg"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information