STOOL SOFTENER- docusate sodium capsule, liquid filled

Stool Softener by

Drug Labeling and Warnings

Stool Softener by is a Otc medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Docusate sodium 100mg

Purpose

Stool softener laxative

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, unles 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 a bowel movement after use of a laxative. These could be a signs of a serious condition.
• you need to use a laxative for more than 1 week

If pregnant or breastfeeding

ask a health care 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

• 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 
• store at 25ºC (77F); excursions permitted between 15-30ºC (59-86ºF)

Inactive Ingredients

edible ink, FD &C red #40, FD &C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol

*may contains this ingredients

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

PRINCIPAL DISPLAY PANEL

DRUG: Stool Softener

GENERIC: Docusate Sodium

DOSAGE: CAPSULE, LIQUID FILLED

ADMINSTRATION: ORAL

NDC: 70518-1127-0

COLOR: orange

SHAPE: OVAL

SCORE: No score

SIZE: 12 mm

IMPRINT: P51;S77;SCU1;D2

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

• DOCUSATE SODIUM 100mg in 1

INACTIVE INGREDIENT(S):

• FD&C RED NO. 40
• WATER
• PROPYLENE GLYCOL
• MEDIUM-CHAIN TRIGLYCERIDES
• SORBITOL
• FD&C YELLOW NO. 6
• GELATIN
• POLYETHYLENE GLYCOL, UNSPECIFIED
• GLYCERIN
• SORBITAN

INGREDIENTS AND APPEARANCE

STOOL SOFTENER 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70518-1127(NDC:0536-1062)
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)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	orange	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	P51;S77;SCU1;D2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70518-1127-0	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	04/19/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	04/19/2018

Labeler - REMEDYREPACK INC. (829572556)