420 Topcare Stool Softener

Drug Facts

Composition & Product

Active Ingredients

Docusate (100 mg)

Inactive Ingredients

Anhydrous Citric Acid D&c Red No. 33 Fd&c Blue No. 1 Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycol 400 Propylene Glycol Sorbitol Solution Water

Identifiers & Packaging

Pill Appearance

Imprint: PC18 Shape: oval Color: red Color: white Size: 13 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2015-04-10

Medication Information

Purpose

Stool softener

Description

Docusate sodium 100mg

Use(s)

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

Storage

store 25°C (77°F) excursions permitted between 15°– 30°C (59°–86°F)

Questions

Call 1-888-952-0050 Monday through Friday 9am-5pm

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 1-3 softgels daily
Children 2 to under 12 years of age : Take 1 softgel 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 capsule contains: sodium 5mg
VERY LOW SODIUM

Active Ingredient(s)

Docusate sodium 100mg

Inactive Ingredients

Black edible ink, citric acid, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special

Pregnancy/breastfeeding

ask a health professional before use.

Principal Display Panel

Stool Softener

Ask A Doctor Before Use If

you have

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

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

Keep Out of Reach of Children

In case of accidental overdose, get medical help or contact a Poison Control Center

(1-800-222-1222) right away.

Structured Label Content

Use(s)

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

Purpose

Stool softener

Storage

store 25°C (77°F) excursions permitted between 15°– 30°C (59°–86°F)

Questions

Call 1-888-952-0050 Monday through Friday 9am-5pm

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 1-3 softgels daily
Children 2 to under 12 years of age : Take 1 softgel 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 capsule contains: sodium 5mg
VERY LOW SODIUM

Active Ingredient(s) (Active ingredient(s))

Docusate sodium 100mg

Inactive Ingredients (Inactive ingredients)

Black edible ink, citric acid, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

ask a health professional before use.

Principal Display Panel

Stool Softener

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

you have

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

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

Keep Out of Reach of Children (Keep out of reach of children)

In case of accidental overdose, get medical help or contact a Poison Control Center

(1-800-222-1222) right away.

Advanced Ingredient Data

[{"name": "DOCUSATE", "unii": "M7P27195AG", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 33", "unii": "9DBA0SBB0L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"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 GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL SOLUTION", "unii": "8KW3E207O2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use(s)": "relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours", "Purpose": "Stool softener", "Storage": "store 25°C (77°F) excursions permitted between 15°– 30°C (59°–86°F)", "Questions": "Call 1-888-952-0050 Monday through Friday 9am-5pm", "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 1-3 softgels daily Children 2 to under 12 years of age : Take 1 softgel 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 capsule contains: sodium 5mg VERY LOW SODIUM", "Active ingredient(s)": "Docusate sodium 100mg", "Inactive ingredients": "Black edible ink, citric acid, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special", "Pregnancy/Breastfeeding": "ask a health professional before use.", "Principal Display Panel": "Stool Softener Stool Softener", "Ask a doctor before use if": "you have stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over a period of 2 weeks ", "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", "Keep out of reach of children": "In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. "}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information