Docusate Sodium 100mg

Docusate Sodium 100mg
SPL v7
SPL
SPL Set ID 31e711c1-24a0-4b57-9f03-3fc22c6bcba0
Route
ORAL
Published
Effective Date 2020-07-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (100 mg)
Inactive Ingredients
Polyethylene Glycol 400 Propylene Glycol Water Gelatin Glycerin Sorbitol Fd&c Red No. 40 Fd&c Yellow No. 6 Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 125 Shape: capsule Color: red Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-07-02

Description

Drug Facts

Purpose

Stool Softner


Medication Information

Warnings and Precautions

Warnings

Purpose

Stool Softner

Description

Drug Facts

Pdp

Cabinet:

Stool Softener

Docusate Sodium 100mg

75 Softgels

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.1(800)222-1222

Section 53414-9

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

uses
  • for temporary relief of occasional constipation and irregularity
  • this product generally produces a bowel movement within 12 to 72 hours
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

1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses

Children 2 to under 12 years of age

1 softgel daily.

Children under 2 years of age

Ask a doctor

Other Information
  • Store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • Keep tightly closed
Inactive Ingredients

FD&C Red#40, FD&C Yellow#6, gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol solution, titanium dioxide.

Questions Or Comments?

1-888-333-9792

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 laxative for more than 1 week.
Active Ingredient (in Each Softgel)

Docusate Sodium 100 mg 

ask A Doctor Before Use If You Have
  • stomach pain, nausea or vomittiong
  • a sudden change in bowel habits that lasts more than 2 weeks

Structured Label Content

Pdp (PDP)

Cabinet:

Stool Softener

Docusate Sodium 100mg

75 Softgels

Warnings and Precautions (34071-1)

Warnings

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.1(800)222-1222

Section 53414-9 (53414-9)

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

Purpose

Stool Softner

uses (Uses)
  • for temporary relief of occasional constipation and irregularity
  • this product generally produces a bowel movement within 12 to 72 hours
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

1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses

Children 2 to under 12 years of age

1 softgel daily.

Children under 2 years of age

Ask a doctor

Other Information (Other information)
  • Store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • Keep tightly closed
Inactive Ingredients (Inactive ingredients)

FD&C Red#40, FD&C Yellow#6, gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol solution, titanium dioxide.

Questions Or Comments? (Questions or comments?)

1-888-333-9792

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 laxative for more than 1 week.
Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Docusate Sodium 100 mg 

ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • stomach pain, nausea or vomittiong
  • a sudden change in bowel habits that lasts more than 2 weeks

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)