DOCUSATE SODIUM- docusate sodium 100mg capsule

Docusate Sodium by

Drug Labeling and Warnings

Docusate Sodium by is a Otc medication manufactured, distributed, or labeled by PHARMAMED USA INC, PHARBEST PHARMACEUTICALS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener

Uses

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

Warnings

Do not use if you are presently taking mineral oil, unless told to do so by a doctor

Ask a doctor before use if you have

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

Stop use and ask a doctor if

• you have rectal bleeding or fail to have bowel movement after use of a laxative. These could be signs of a serious condition.
• you need to use a stool softener 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. (1 800-222-1222)

Directions

• 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 1-3 softgels daily
• children 2 to under 12 years of age: take 1 softgel daily
• children under 2 years: ask a doctor

Other information

• each softgel contains: sodium 6 mg
• VERY LOW SODIUM
• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF).

keep tightly closed.

Inactive ingredients

D&C Red #33, edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, titanium dioxide

Questions or comments?

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

Package Label Principal Display Panel

PHARMAMED

NDC: 84289-399-01

Manufactured in the U.S.A

Docusate

Sodium

100 softgels

100mg each

*Compare to the active ingredient of Colace*

THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDREN

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium 100mg capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84289-399(NDC:16103-399)
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
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)

Product Characteristics
Color	red (TWO-TONED- WHITE AND CLEAR RED)	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	SCU2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84289-399-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	10/01/2024

Labeler - PHARMAMED USA INC (065607328)

Registrant - PHARBEST PHARMACEUTICALS, INC. (557054835)

Establishment
Name	Address	ID/FEI	Business Operations
PHARBEST PHARMACEUTICALS, INC.		557054835	repack(84289-399)