docusate sodium 100 mg............... stool softener

docusate sodium 100 mg............... stool softener
SPL v4
SPL
SPL Set ID 93158bd3-c830-4b12-ab1c-133a4bdb9c78
Route
oral
Published
Effective Date 2021-07-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
docusate (100 mg)
Inactive Ingredients
fd&c red no. 40 fd&c yellow no. 6 gelatin polyethylene glycol, unspecified glycerin sorbitol water

Identifiers & Packaging

Pill Appearance
Imprint: SCU1 Shape: capsule Color: red Size: 12 mm Score: 1
Marketing Status
otc monograph drug active Since 2021-07-20

Purpose

Stool softener

Description

Drug Facts


Medication Information

Uses
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 12 to 72 hours
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 3 softgels daily

children 2 to under 12 years of age

take 1 softgel daily

children under 2 years

ask a doctor

Other Information
  • each softgel contains: sodium 7 mg
  • store at room temperature 15° to 30°C (59° to 86°F)
Inactive Ingredients

FD&C RED NO. 40, FD&C YELLOW NO. 6, GELATIN BOVINE, GLYCEROL, POLYETHYLENE GLYCOL, PURIFIED WATER, SORBITOL.

Description

Drug Facts

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 50569-3

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel movements that lasts over 2 weeks
Section 53414-9

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

Do Not Use
  • if you are presently taking mineral oil, unless told to do so by a doctor                                
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DISTRIBUTED BY

TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007

©TOPCO RSEA0621

QUESTIONS? 1-888-423-0139

[email protected]

www.topcarebrand.com

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 100 mg


Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 12 to 72 hours
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 3 softgels daily

children 2 to under 12 years of age

take 1 softgel daily

children under 2 years

ask a doctor

Other Information (Other information)
  • each softgel contains: sodium 7 mg
  • store at room temperature 15° to 30°C (59° to 86°F)
Inactive Ingredients

FD&C RED NO. 40, FD&C YELLOW NO. 6, GELATIN BOVINE, GLYCEROL, POLYETHYLENE GLYCOL, PURIFIED WATER, SORBITOL.

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 50569-3 (50569-3)

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel movements that lasts over 2 weeks
Section 53414-9 (53414-9)

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

Do Not Use (Do not use)
  • if you are presently taking mineral oil, unless told to do so by a doctor                                
Display Panel

DISTRIBUTED BY

TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007

©TOPCO RSEA0621

QUESTIONS? 1-888-423-0139

[email protected]

www.topcarebrand.com

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 100 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)