DOCUSATE SODIUM capsule

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active Ingredient (in each softgel)

Docusate Sodium 100 mg

PURPOSE

Purpose

Stool softener

Uses

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

Warnings

Do not use if you are currently taking mineral oil, unless told to do so by a doctor

Ask a doctor before use if you have

• stomach pain, nausea or vomiting
• noticed a sudden change in bowel habits that lasts over 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

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding, 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 immediately 1 (800) 222-1222

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 of age: ask a doctor

Other information

• each capsule contains: sodium 6 mg
• VERY LOW SODIUM
• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF).
• keep tightly closed.

INACTIVE INGREDIENT

Inactive Ingredients: D&C Red # 33, Edible Ink, FD&C Red # 40, FD&C Yellow # 6, Gelatin, Glycerin, Polyethylene Glycol, Purified Water, Sorbitol Special, titanium dioxide

QUESTIONS

Questions or comments? (877) 367-3250

Package Label Principal Display Panel

NDC: 81877-840-90

Forreal Pharmaceuticals LLC
YOUR SOLUTION TO BETTER HEALTHCARE.

Docusate
Sodium

Stool Softener

100 mg

90 Softgels

TAMPER EVIDENT: DO NOT USE IF SEAL IS BROKEN OR MISSING FROM BOTTLE.

Marketed By:
Forreal Pharmaceuticals, LLC
Royal Oak MI 48067
Questions or inquiries call
877-367-3250

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81877-840
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	RED (Two-toned- white and clear red)	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	SCU2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81877-840-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/01/2026

Labeler - Forreal Pharmaceuticals, LLC (118029197)