Stool Softener

Manufacturer: REMEDYREPACK INC.
Effective date: 2021-12-23
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-01 22:21:19

Label at a glance#

ProductStool Softener

Active ingredientDOCUSATE CALCIUM

Label structure9 sections

Indications and uses

for relief of occasional constipation. this product generally produces a bowel movement within 12 to72 hours.

Dosage and administration

adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor children under 12 years of age: ask a doctor.

Storage and handling

store between 20º-25ºC (68º-77ºF);excursions permitted between 15º-30ºC (59º-86ºF)

Contacts and useful links#

PhoneLabel contact1-877-753-3935

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate Calcium 240mg

Purpose

OTC - PURPOSE SECTION

Stool softener laxative

Uses

INDICATIONS & USAGE SECTION

for relief of occasional constipation.
this product generally produces a bowel movement within 12 to72 hours.

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

if you are currently taking mineral oil, unless directed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
you need to use a laxative for more than 1 week

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor
children under 12 years of age: ask a doctor.

Other information

STORAGE AND HANDLING SECTION

store between 20º-25ºC (68º-77ºF);excursions permitted between 15º-30ºC (59º-86ºF)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

corn oil, D&C red #33*, edible white ink, FD&C blue #1*, FD&C Red #40, FD&C yellow ≠≠6*, gelatin, glycerin, purified water and sorbitol special.

*contains one or more of these ingredients

Questions or comments?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Stool Softener

GENERIC: Docusate calcium

DOSAGE: CAPSULE, LIQUID FILLED

ADMINSTRATION: ORAL

NDC: 70518-3013-0

NDC: 70518-3013-1

COLOR: red

SHAPE: CAPSULE

SCORE: No score

SIZE: 18 mm

IMPRINT: P58;SCU

PACKAGING: 1 in 1 POUCH

OUTER PACKAGING: 100 in 1 BOX

ACTIVE INGREDIENT(S):

DOCUSATE CALCIUM 240mg in 1

INACTIVE INGREDIENT(S):

CORN OIL
D&C RED NO. 33
FD&C RED NO. 40
GELATIN
GLYCERIN
WATER
SORBITOL
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
SORBITAN

Remedy_Label

MM2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-3013-0	2023-10-16	C162847	48780-1	f386c649-99e1-0266-e053-dadaa90a7c1a	Drug Facts
70518-3013-0	2023-01-30	C162847	48780-1	f386c649-99e1-0266-e053-dadaa90a7c1a	Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0536-1065-01	EA - Each	0536-1065	db131ae2-b8fb-45a7-b687-4a15ec7f2d0c	1	2015-07-20
0536-1065-05	EA - Each	0536-1065	be573f16-82eb-4c7c-a516-17ca49e8cd5a	1	2015-07-20
0536-1065-10	EA - Each	0536-1065	ff946148-60be-4615-af5a-1920e17c2772	1	2015-09-10

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

Stool Softener
Docusate calcium
CORN OIL
D&C RED NO. 33
FD&C RED NO. 40
GELATIN
GLYCERIN
WATER
SORBITOL
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
SORBITAN
DOCUSATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70518-3013	70518-3013-1, 70518-3013-0
0536-1065

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CORN OIL	8470G57WFM	IACT
D&C RED NO. 33	9DBA0SBB0L	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
SORBITAN	6O92ICV9RU	IACT
DOCUSATE CALCIUM	6K7YS503HC	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
f6e1df6e-b158-7d16-e053-6294a90a8481			ccc9ef97-72f0-48f6-a93f-541a6d7132aa	2023-03-14	Warnings	Exact identifier spl set id: ccc9ef97-72f0-48f6-a93f-541a6d7132aa

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.