STOOL SOFTENER- docusate sodium capsule, liquid filled
REMEDYREPACK INC.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Drug Facts

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?

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

PRINCIPAL DISPLAY PANEL

DRUG: Stool Softener

GENERIC: Docusate Sodium

DOSAGE: CAPSULE, LIQUID FILLED

ADMINSTRATION: ORAL

NDC: 70518-1127-0

NDC: 70518-1127-1

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

MM1

MM2

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

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 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)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SORBITAN (UNII: 6O92ICV9RU)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70518-1127-0	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	04/19/2018	04/24/2018
2	NDC:70518-1127-1	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	01/23/2021	10/13/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		04/19/2018	10/13/2023

Labeler - REMEDYREPACK INC. (829572556)

Revised: 10/2023

Document Id: 079e140a-b39f-1c2e-e063-6394a90a8491

Set id: eed75056-bd37-4134-9e8f-bd5580b4f8a2

Version: 8

Effective Time: 20231013

REMEDYREPACK INC.