Stool Softener Docusate Sodium 50mg, capsule, Liquid Filled

Drug Facts

Composition & Product

Active Ingredients

Docusate (50 mg)

Inactive Ingredients

Fd&c Red No. 40 D&c Red No. 33 Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycol, Unspecified Propylene Glycol Water Sorbitol Anhydrous Citric Acid

Identifiers & Packaging

Pill Appearance

Imprint: PC20 Shape: capsule Color: red Size: 13 mm Score: 1

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2016-12-14

Medication Information

Purpose

Stool softener

Description

Drug Facts

Uses

relieves occasional constipation (irregularity)
generally produces bowel movement in 12 to 72 hours

Section 42229-5

Drug Facts

Section 50565-1

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

Section 53414-9

If pregnant or breast-feeding, ask a health 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 and over	take 1 to 6 softgels daily
Children 2 to under 12 years of age	take 1 to 3 softgels daily
children under 2 years	ask a doctor

Do Not Use

if you are presently taking mineral oil, unless told to do so by a doctor

Other Information

each softgel contains: sodium 3 mg

VERY LOW SODIUM
store at 15°-30°C (59°-86°F)
Keep tightly closed.

Inactive Ingredients

citric acid, D&C red #33, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, white edible ink

Manufactured by:

Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.

Wuhan, Hubei 430206,

China

Stop Use and Ask A Doctor If

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
you need to use a stool softener laxative for more than 1 week

Active Ingredient (in Each Softgel)

Docusate Sodium 50 mg

Ask A Doctor Before Use If You Have

stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that lasts over 2 weeks

Principal Display Panel 30ct Carton and Bottle Label

STOOL SOFTENER DOCUSATE SODIUM 50 MG 30ct

NDC 69842-072-20

Compare to the active ingredient in Colace ^® 50 mg

Principal Display Panel 100ct Carton and Bottle Label

STOOL SOFTENER DOCUSATE SODIUM 50 MG 100ct

NDC 69842-072-24

Compare to the active ingredient in Colace^® 50 mg

Structured Label Content

Uses

relieves occasional constipation (irregularity)
generally produces bowel movement in 12 to 72 hours

Section 42229-5 (42229-5)

Drug Facts

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.

Section 53414-9 (53414-9)

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

Purpose

Stool softener

Directions

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

Adults and children 12 years and over	take 1 to 6 softgels daily
Children 2 to under 12 years of age	take 1 to 3 softgels daily
children under 2 years	ask a doctor

Do Not Use (Do not use)

if you are presently taking mineral oil, unless told to do so by a doctor

Other Information (Other information)

each softgel contains: sodium 3 mg

VERY LOW SODIUM
store at 15°-30°C (59°-86°F)
Keep tightly closed.

Inactive Ingredients (Inactive ingredients)

citric acid, D&C red #33, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, white edible ink

Manufactured by:

Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.

Wuhan, Hubei 430206,

China

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

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
you need to use a stool softener laxative for more than 1 week

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

Docusate Sodium 50 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that lasts over 2 weeks

Principal Display Panel 30ct Carton and Bottle Label (PRINCIPAL DISPLAY PANEL - 30ct Carton and Bottle Label)

STOOL SOFTENER DOCUSATE SODIUM 50 MG 30ct

NDC 69842-072-20

Compare to the active ingredient in Colace ^® 50 mg

Principal Display Panel 100ct Carton and Bottle Label (PRINCIPAL DISPLAY PANEL - 100ct Carton and Bottle Label)

STOOL SOFTENER DOCUSATE SODIUM 50 MG 100ct

NDC 69842-072-24

Compare to the active ingredient in Colace^® 50 mg

Advanced Ingredient Data

[{"name": "DOCUSATE", "unii": "M7P27195AG", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 33", "unii": "9DBA0SBB0L", "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 GLYCOL, UNSPECIFIED", "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": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Stool softener", "Directions": "Take only by mouth. Doses may be taken as a single daily dose or in divided doses. Adults and children 12 years and over take 1 to 6 softgels daily Children 2 to under 12 years of age take 1 to 3 softgels daily children under 2 years ask a doctor", "Do not use": "if you are presently taking mineral oil, unless told to do so by a doctor ", "Other information": "each softgel contains: sodium 3 mg VERY LOW SODIUM store at 15°-30°C (59°-86°F) Keep tightly closed.", "Inactive ingredients": "citric acid, D&C red #33, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, white edible ink Manufactured by: Humanwell PuraCap Pharmaceutical (Wuhan) Ltd. Wuhan, Hubei 430206, China", "Stop use and ask a doctor if": "you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. you need to use a stool softener laxative for more than 1 week", "Active ingredient (in each softgel)": "Docusate Sodium 50 mg", "Ask a doctor before use if you have": "stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks", "PRINCIPAL DISPLAY PANEL - 30ct Carton and Bottle Label": "STOOL SOFTENER DOCUSATE SODIUM 50 MG 30ct NDC 69842-072-20 Compare to the active ingredient in Colace ® 50 mg", "PRINCIPAL DISPLAY PANEL - 100ct Carton and Bottle Label": "STOOL SOFTENER DOCUSATE SODIUM 50 MG 100ct NDC 69842-072-24 Compare to the active ingredient in Colace ® 50 mg"}

Stool Softener Docusate Sodium 50mg, capsule, Liquid Filled

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information