Docusate Sodium Es

SPL v1

SPL

SPL Set ID e05cd4e1-e2e9-450f-9371-30eddd35006d

Route

ORAL

Published

Effective Date 2012-09-14

Document Type 34390-5 HUMAN OTC DRUG LABEL

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 2012-03-29

Description

Docusate Sodium 250mg

Purpose

Stool softener

Medication Information

Purpose

Stool softener

Description

Docusate Sodium 250mg

Uses

Relieves occasional constipation.
Generally produces bowel movement within 12 to72 hours.

Directions

adults and children over 12 years and over:1 capsule once daily
children under 12 years: ask a doctor

Package Label

NDC 66336-0010-XX

Product Labeling

Rugby Extra Strength Stool Softener Laxative

Docusate Sodium USP, 250mg

Mfd for: Rugby Laboratories, Inc

Duluth Georgia 30097

www.rugbylaboratories.com

Other Information

store at controlled room temperature 15 - 30 degrees C (59-86 degrees F)

Each capsule contains sodium 15mg

Inactive Ingredients

edible white ink, FDandC Red No. 40, FDandC Yellow No. 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified wter, sorbitol special.

Warnings Do Not Use

for longer than one week
if you are taking mineral oil
when abdominal pain, nausea, or vomiting are present

Questions Or Comments?

Call 1-800-645-2158, 9am - 5am ET Monday - Friday

Ask A Doctor Before Use If

you have a sudden change in bowel habits that lasts over two weeks

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

If Pregnant Or Breastfeeding

ask a health professional before use.

Stop Use and Ask A Doctor If

you experience rectal bleeding
you fail to have a bowel movement after using this product

These may indicate a serious condition.

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 250mg

Structured Label Content

Uses

Relieves occasional constipation.
Generally produces bowel movement within 12 to72 hours.

Purpose

Stool softener

Directions

adults and children over 12 years and over:1 capsule once daily
children under 12 years: ask a doctor

Package Label

NDC 66336-0010-XX

Product Labeling

Rugby Extra Strength Stool Softener Laxative

Docusate Sodium USP, 250mg

Mfd for: Rugby Laboratories, Inc

Duluth Georgia 30097

www.rugbylaboratories.com

Other Information (Other information)

store at controlled room temperature 15 - 30 degrees C (59-86 degrees F)

Each capsule contains sodium 15mg

Inactive Ingredients

edible white ink, FDandC Red No. 40, FDandC Yellow No. 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified wter, sorbitol special.

Warnings Do Not Use (Warnings - Do not use)

for longer than one week
if you are taking mineral oil
when abdominal pain, nausea, or vomiting are present

Questions Or Comments? (Questions or comments?)

Call 1-800-645-2158, 9am - 5am ET Monday - Friday

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

you have a sudden change in bowel habits that lasts over two weeks

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

ask a health professional before use.

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

you experience rectal bleeding
you fail to have a bowel movement after using this product

These may indicate a serious condition.

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 250mg

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": "Relieves occasional constipation. Generally produces bowel movement within 12 to72 hours.", "Purpose": "Stool softener", "Directions": "adults and children over 12 years and over: 1 capsule once daily children under 12 years : ask a doctor", "Package Label": "NDC 66336-0010-XX", "Product Labeling": "Rugby Extra Strength Stool Softener Laxative Docusate Sodium USP, 250mg Mfd for: Rugby Laboratories, Inc Duluth Georgia 30097 www.rugbylaboratories.com", "Other information": "store at controlled room temperature 15 - 30 degrees C (59-86 degrees F) Each capsule contains sodium 15mg", "Inactive Ingredients": "edible white ink, FDandC Red No. 40, FDandC Yellow No. 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified wter, sorbitol special.", "Warnings - Do not use": "for longer than one week if you are taking mineral oil when abdominal pain, nausea, or vomiting are present", "Questions or comments?": "Call 1-800-645-2158, 9am - 5am ET Monday - Friday", "Ask a doctor before use if": "you have a sudden change in bowel habits that lasts over two weeks Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.", "If pregnant or breastfeeding": "ask a health professional before use.", "Stop use and ask a doctor if": "you experience rectal bleeding you fail to have a bowel movement after using this product These may indicate a serious condition.", "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 250mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:31.424 · Updated: 2026-03-14T22:53:16.318838