Docusate Sodium by Direct_Rx Docusate Sodium

Docusate Sodium by

Drug Labeling and Warnings

Docusate Sodium by is a Otc medication manufactured, distributed, or labeled by Direct_Rx. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOCUSATE SODIUM- docusate sodium capsule, liquid filled 
Direct_Rx

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Docusate Sodium

Ask a doctor before use if you

have stomach pain, nausea or vomiting

have a sudden change in bowel habits that persists over a period of 2 weeks

are presently taking mineral oil

Stop use and ask a doctor if

you need to use a laxative longer than 1 week

you have rectal bleeding or fail to have a bowel movement. These

could be signs of a serious condition.

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.

Docusate Sodium 100 mg

Stool Softener Laxative

relieves occasional constipation (irregularity)

generally produces bowel movement in 12 to 72 hours

FD&C red #40, FD&C yellow #6 (sunset yellow), gelatin, glycerin, PEG, sorbitol special, water.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

each softgel contains: sodium 7 mg. Very low sodium

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72189-377(NDC: 57896-401)
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
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
GELATIN (UNII: 2G86QN327L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MANNITOL (UNII: 3OWL53L36A)

Product Characteristics
Color	red (reddish)	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	SCU1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72189-377-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2022	10/09/2023
2	NDC: 72189-377-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2022	10/09/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	08/31/2022	10/09/2023

Labeler - Direct_Rx (079254320)

Registrant - Direct_Rx (079254320)

Establishment
Name	Address	ID/FEI	Business Operations
Direct_Rx		079254320	repack(72189-377)

Revised: 10/2023

Document Id: 07d9b739-eacf-d06a-e063-6294a90a7413

34390-5

Set id: e78dceed-6b04-275a-e053-2a95a90a59bf

Version: 5

Effective Time: 20231016