Stool Softener Regular Strength

Stool Softener Regular Strength
SPL v6
SPL
SPL Set ID 46be4007-399f-4e43-9330-ac36f2de96ef
Route
ORAL
Published
Effective Date 2021-11-22
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 Glycerin Polyethylene Glycol 400 Povidone Propylene Glycol Water Sorbitol Solution Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 125 Shape: oval Color: red Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-11-22

Description

Docusate sodium 100 mg

Purpose

Stool softener


Medication Information

Purpose

Stool softener

Description

Docusate sodium 100 mg

Uses

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

Pouch

Warnings

Directions

take only by mouth. Doses may be taken as asingle daily dose or in divided doses.

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

Do Not Use

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

Drug Facts

Distributed By:

Cabinet Health P.B.C.

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, povidone, propylene glycol, purified water, sorbitol solution

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 a stool softener laxative for more than 1 week

If Pregnant Or Breast Feeding,

ask a health professional before use.

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)

Active Ingredient (in Each Tablet)

Docusate sodium 100 mg

Ask A Doctor Before Use If You Have

• fever • mucus in the stool

Ask A Doctor Or Pharmacist Before Use If You Are If You Have

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


Structured Label Content

Uses

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

Pouch

Purpose

Stool softener

Warnings

Directions

take only by mouth. Doses may be taken as asingle daily dose or in divided doses.

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

Do Not Use (Do not use)

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

Drug Facts

Distributed By: (Distributed by:)

Cabinet Health P.B.C.

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, povidone, propylene glycol, purified water, sorbitol solution

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 a stool softener laxative for more than 1 week

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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)

Active Ingredient (in Each Tablet) (Active Ingredient (in each tablet))

Docusate sodium 100 mg

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

• fever • mucus in the stool

Ask A Doctor Or Pharmacist Before Use If You Are If You Have (Ask a doctor or pharmacist before use if you are if you have)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)