Docusate Sodium, Usp

Drug Facts

Composition & Product

Active Ingredients

Docusate (100 mg)

Inactive Ingredients

Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin, Unspecified Glycerin Polyethylene Glycol 400 Water Sorbitol

Identifiers & Packaging

Pill Appearance

Imprint: SCU1 Shape: oval Color: red Size: 12 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2016-01-19

Medication Information

Purpose

Stool softener laxative

Description

Docusate Sodium 100 mg

Uses

for relief of occasional constipation (irregularity)
generally produces a bowel movement within 12 to 72 hours

Section 50565-1

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

Warnings

Do not use

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

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 or you fail to have a bowel movement after use of a laxative. This may indicate a serious condition.

If pregnant or breast-feeding, ask a health care professional before use.

Directions

Take only by mouth. Doses may be taken as a single daily dose or in divided doses.

adults and children 12 years of age and over	take 1 to 3 softgels daily
children 2 to under 12 years of age	take 1 softgel daily
children under 2 years of age	ask a doctor

Other Information

Each softgel contains: sodium 7 mg VERY LOW SODIUM
Store at room temperature between 15° to 30°C (59° to 86°F)
FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Inactive Ingredients

FD&C Red #40, FD&C Yellow #6, Gelatin USP, Glycerin USP, Polyethylene Glycol 400 NF, Purified Water USP, Sorbital USP

The drug product contained in this package is from NDC # 61301-8001, SWISSCAPS Romania srl.

Distributed by:

American Health Packaging

2550 John Glenn Avenue, Suite A

Columbus, OH 43217

712901

0412901/0216PS

Active Ingredient (in Each Softgel)

Docusate Sodium 100 mg

Principal Display Panel Blister – 100 Mg

DOCUSATE SODIUM, USP

Stool Softener Laxative

Softgel 100 mg

Principal Display Panel – Carton – 100 Mg

NDC 60687- 129-01

DOCUSATE SODIUM, USP

Stool Softener Laxative

100 mg

100 Softgels (10 x 10)

The drug product contained in this package is from

NDC # 61301-8001, SWISSCAPS Romania srl.

Packaged and Distributed by:

American Health Packaging

Columbus, OH 43217

712901

0412901/0119

Structured Label Content

Uses

for relief of occasional constipation (irregularity)
generally produces a bowel movement within 12 to 72 hours

Section 50565-1 (50565-1)

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

Purpose

Stool softener laxative

Warnings

Do not use

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

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 or you fail to have a bowel movement after use of a laxative. This may indicate a serious condition.

If pregnant or breast-feeding, ask a health care professional before use.

Directions

Take only by mouth. Doses may be taken as a single daily dose or in divided doses.

adults and children 12 years of age and over	take 1 to 3 softgels daily
children 2 to under 12 years of age	take 1 softgel daily
children under 2 years of age	ask a doctor

Other Information (Other information)

Each softgel contains: sodium 7 mg VERY LOW SODIUM
Store at room temperature between 15° to 30°C (59° to 86°F)
FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Inactive Ingredients (Inactive ingredients)

FD&C Red #40, FD&C Yellow #6, Gelatin USP, Glycerin USP, Polyethylene Glycol 400 NF, Purified Water USP, Sorbital USP

The drug product contained in this package is from NDC # 61301-8001, SWISSCAPS Romania srl.

Distributed by:

American Health Packaging

2550 John Glenn Avenue, Suite A

Columbus, OH 43217

712901

0412901/0216PS

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

Docusate Sodium 100 mg

Principal Display Panel Blister – 100 Mg (Principal Display Panel - Blister – 100 mg)

DOCUSATE SODIUM, USP

Stool Softener Laxative

Softgel 100 mg

Principal Display Panel – Carton – 100 Mg (Principal Display Panel – Carton – 100 mg)

NDC 60687- 129-01

DOCUSATE SODIUM, USP

Stool Softener Laxative

100 mg

100 Softgels (10 x 10)

The drug product contained in this package is from

NDC # 61301-8001, SWISSCAPS Romania srl.

Packaged and Distributed by:

American Health Packaging

Columbus, OH 43217

712901

0412901/0119

Advanced Ingredient Data

[{"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, UNSPECIFIED", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "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": ""}, {"name": "DOCUSATE", "unii": "M7P27195AG", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "for relief of occasional constipation (irregularity) generally produces a bowel movement within 12 to 72 hours", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Purpose": "Stool softener laxative", "Warnings": "Do not use if you are currently taking mineral oil, unless directed by a doctor when abdominal pain, nausea or vomiting are present unless directed by a doctor for longer than one week unless directed by a doctor 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 or you fail to have a bowel movement after use of a laxative. This may indicate a serious condition. If pregnant or breast-feeding, ask a health care professional before use.", "Directions": "Take only by mouth. Doses may be taken as a single daily dose or in divided doses. adults and children 12 years of age and over take 1 to 3 softgels daily children 2 to under 12 years of age take 1 softgel daily children under 2 years of age ask a doctor", "Other information": "Each softgel contains: sodium 7 mg VERY LOW SODIUM Store at room temperature between 15° to 30°C (59° to 86°F) FOR YOUR PROTECTION: Do not use if blister is torn or broken.", "Inactive ingredients": "FD&C Red #40, FD&C Yellow #6, Gelatin USP, Glycerin USP, Polyethylene Glycol 400 NF, Purified Water USP, Sorbital USP The drug product contained in this package is from NDC # 61301-8001, SWISSCAPS Romania srl. Distributed by: American Health Packaging 2550 John Glenn Avenue, Suite A Columbus, OH 43217 712901 0412901/0216PS", "Active ingredient (in each softgel)": "Docusate Sodium 100 mg", "Principal Display Panel - Blister – 100 mg": "DOCUSATE SODIUM, USP Stool Softener Laxative Softgel 100 mg", "Principal Display Panel – Carton – 100 mg": "NDC 60687- 129 -01 DOCUSATE SODIUM, USP Stool Softener Laxative 100 mg 100 Softgels (10 x 10) The drug product contained in this package is from NDC # 61301-8001, SWISSCAPS Romania srl. Packaged and Distributed by: American Health Packaging Columbus, OH 43217 712901 0412901/0119"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information