DOCUSATE SODIUM capsule, liquid filled

Docusate Sodium by

Drug Labeling and Warnings

Docusate Sodium by is a Otc medication manufactured, distributed, or labeled by Asclemed USA, Inc., ASCLEMED USA INC. DBA ENOVACHEM. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

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 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.

Directions

do not exceed recommended dose
adults and children 12 years and older: take 1-3
softgels daily until first bowel movement; 1 softgel
daily thereafter, or as directed by a doctor
children under 12: consult a doctor

Other information

each softgel contains: sodium 7 mg. Very low sodium
store at 59°-77°F (15°-25°C)
keep tightly closed
Tamper Evident: Do not use if imprinted seal
under cap is missing or broken.

Inactive ingredients

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

PATIENT PACKAGE INSERT

Repackaged/Relabeled by:
Enovachem PHARMACEUTICALS
Torrance, CA 90501

Package Label

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76420-225(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
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
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: 76420-225-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	07/07/2022
2	NDC: 76420-225-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	07/07/2022
3	NDC: 76420-225-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	07/07/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	01/01/2000

Labeler - Asclemed USA, Inc. (059888437)

Establishment
Name	Address	ID/FEI	Business Operations
ASCLEMED USA INC. DBA ENOVACHEM		059888437	repack(76420-225) , relabel(76420-225)