Major 44-655

Major 44-655
SPL v10
SPL
SPL Set ID ae457a19-ad08-49e6-94f0-3e5799fbef7d
Route
ORAL
Published
Effective Date 2021-03-01
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, Unspecified Glycerin Polyethylene Glycol, Unspecified Propylene Glycol Sorbitol Water Anhydrous Citric Acid

Identifiers & Packaging

Pill Appearance
Imprint: 655 Shape: oval Color: orange Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-03-01
Description

Docusate sodium 100 mg

Purpose

Stool softener laxative

How Supplied

Product: 50090-2842 NDC: 50090-2842-0 1 CAPSULE, LIQUID FILLED in a BLISTER PACK / 33 in a BOX, UNIT-DOSE

Medication Information

Purpose

Stool softener laxative

How Supplied

Product: 50090-2842

NDC: 50090-2842-0 1 CAPSULE, LIQUID FILLED in a BLISTER PACK / 33 in a BOX, UNIT-DOSE

Description

Docusate sodium 100 mg

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours
Directions
  • take with a glass of water
  • 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 capsules daily
 children 2 to under 12 years  take 1 capsule 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.

Docusate Sodium
Other Information
  • each capsule contains: sodium 6 mg Very Low Sodium
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from excessive humidity
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • see end flap for expiration date and lot number
Inactive Ingredients

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

Questions Or Comments?

(800) 616-2471

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

Ask A Doctor Before Use If You Have
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks
Active Ingredient (in Each Liquid Filled Capsule)

Docusate sodium 100 mg

Structured Label Content

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

Stool softener laxative

Directions
  • take with a glass of water
  • 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 capsules daily
 children 2 to under 12 years  take 1 capsule 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.

How Supplied (HOW SUPPLIED)

Product: 50090-2842

NDC: 50090-2842-0 1 CAPSULE, LIQUID FILLED in a BLISTER PACK / 33 in a BOX, UNIT-DOSE

Docusate Sodium
Other Information (Other information)
  • each capsule contains: sodium 6 mg Very Low Sodium
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • protect from excessive humidity
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

(800) 616-2471

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

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
Active Ingredient (in Each Liquid Filled Capsule) (Active ingredient (in each liquid-filled capsule))

Docusate sodium 100 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:26.382535 · Updated: 2026-03-14T22:59:24.470306