DOCUSATE SODIUM- docusate sodium capsule, liquid filled
Cardinal Health 107, LLC

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Docusate Sodium

Active ingredient (in each liquid-filled capsule)

Docusate sodium 100 mg

Purpose

Stool softener laxative

Uses

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

Warnings

Ask a doctor before use if you have

•: stomach pain
•: nausea
•: vomiting
•: noticed a sudden change in bowel habits that lasts over 2 weeks

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 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 right away.

Directions

•: do not take more than directed
•: 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

Other information

•: each capsule contains: sodium 8 mg
Very Low Sodium
•: store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
•: protect from light, heat and moisture
•: 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

FD&C red #40, FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, light mineral oil, medium chain triglycerides, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution, white ink

Questions or comments?

(800) 616-2471

Distributed By:

Cardinal Health

Dublin, OH 43017

L57365330921

Principal Display Panel

Docusate Sodium

Unit Dose

10 Softgels

DOCUSATE SODIUM
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55154-2340(NDC:0904-7115)
Route of Administration	ORAL

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)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	752
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55154-2340-0	10 in 1 BAG	04/16/2021	08/13/2023
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	04/16/2021	08/13/2023

Labeler - Cardinal Health 107, LLC (118546603)

Name	Address	ID/FEI	Business Operations
Establishment
Aphena Pharma Solutions - Tennessee, LLC		118348161	REPACK(55154-2340)

Revised: 11/2023

Document Id: b653f9dd-d857-4012-883d-1c8123bb7735

Set id: c4c3e92e-9d35-4a1e-96c6-b7e38f48ae67

Version: 3

Effective Time: 20231116

Cardinal Health 107, LLC