DOCUSATE SODIUM - STOOL SOFTENER LAXATIVE- docusate sodium capsule, liquid filled

Docusate Sodium - Stool Softener Laxative by

Drug Labeling and Warnings

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

 for relief of occasional constipation (irregularity)
 This generally produces a bowel movement within 12 to 72 hours.

Warnings

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 softgels with a full glass (8 oz) of water

• adults and children 12 years of age and 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 10 mg (very low sodium)
 store at 25°C (77°F) in a dry place. Avoid excessive heat 40°C (140°F).

Inactive ingredients

edible white ink, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, isopropyl alcohol, light mineral oil, medium chain triglycerides, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution

Questions or comments? 

(800)616-2471​

SPL UNCLASSIFIED SECTION

MAJOR®

Unit Dose

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

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268

Product of UAE
Packaged and Quality Assured in the USA

Packaging

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM - STOOL SOFTENER LAXATIVE 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-7183
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)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	777
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-7183-61	10 in 1 CARTON	09/04/2021
1		10 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	09/04/2021

Labeler - Major Pharmaceuticals (191427277)