DOCUSATE SODIUM capsule, liquid filled

MAJOR docusate sodium stool softener laxative by

Drug Labeling and Warnings

MAJOR docusate sodium stool softener laxative by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener laxative

Uses

 relieves occasional constipation (irregularity)
 this product generally produces a bowel movement within 12 to 72 hours.

Warnings

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

Ask a doctor before use if you have
 abdominal pain, nausea, or vomiting
 a sudden change in bowel habits that lasts over 14 days

Ask a doctor or pharmacist before use if you are presently taking mineral oil

Stop use and ask a doctor if
you have rectal bleeding or no bowel movement after using this product. These can 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 care professional before use.

Keep out of reach of children
Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

 take only by mouth  take softgels with a full glass (8 oz) of water

• adults and children 12 years of ageand older: take 1 to 3 softgels daily or as directed; by a doctor. This dose may be taken as; a single daily dose or in divided doses.
• children 6 to under 12 years of age: take 1 softgel daily or as directed by; a doctor
• children under 6 years of age: ask a doctor

Other information

each softgel contains: sodium 5 mg (very low sodium)
 store at controlled room temperature 20–25°C (68–77°F)
 protect from light, heat and moisture

Inactive ingredients

FD&C Red No.40, FD&C Yellow No.6, gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol sorbitan solution

Questions or comments?

1(888) 577-8033

SPL UNCLASSIFIED SECTION

NDC: 0904-7609-61

MAJOR® docusate sodium 

docusate sodium 100 mg

stool softener
laxative

stimulant-free
relief of occasional constipation

100 softgels

(10x10) unit dose

Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
(800) 616-2471

www.major-rugby.com
Made in India
CT0904760961
REV.00-092025

Rev. 10/25 M-173 Re-order No. 701455

READ AND KEEP OUTER CARTON FOR COMPLETE
PRODUCT WARNINGS AND INFORMATION

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

Packaging

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-7609
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
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	D1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-7609-61	100 in 1 CARTON	11/25/2025
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	11/25/2025

Labeler - Major Pharmaceuticals (191427277)