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

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).

Overbagged with 10 liquid-filled capsules per bag, NDC: 55154-3369-0

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.
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

Distributed By:

Cardinal Health

Dublin, OH 43017

L57466800124

Product of UAE
Packaged and Quality Assured in the USA

CT0904718361

REV.01-032022
Principal Display Panel

NDC: 55154-3369-0

DOCUSATE SODIUM 100 mg

Stool Softener Laxative

10 SOFTGELS

INGREDIENTS AND APPEARANCE

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 55154-3369-0	10 in 1 BAG	09/04/2021
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M007	09/04/2021

Labeler - Cardinal Health 107, LLC (118546603)

Docusate Sodium - Stool Softener Laxative by