STOOL SOFTENER- docusate calcium 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 Calcium 240mg

Purpose

Stool softener laxative

Uses

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

Warnings

Do not use

if you are currently taking mineral oil, unless directed 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 signs of a serious condition.
you need to use a laxative for more than 1 week

If pregnant or breastfeeding

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

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

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

Inactive Ingredients

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?

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

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

STOOL SOFTENER
docusate calcium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70518-3013(NDC:0536-1065)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE CALCIUM (UNII: 6K7YS503HC) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE CALCIUM	240 mg

Ingredient Name	Strength
Inactive Ingredients
CORN OIL (UNII: 8470G57WFM)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	red	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	P58;SCU
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70518-3013-0	100 in 1 BOX	02/02/2021	02/05/2021
1	NDC:70518-3013-1	1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		02/02/2021	02/05/2021

Labeler - REMEDYREPACK INC. (829572556)

Revised: 3/2023

Document Id: f6e1df6e-b158-7d16-e053-6294a90a8481

Set id: ccc9ef97-72f0-48f6-a93f-541a6d7132aa

Version: 2

Effective Time: 20230314

REMEDYREPACK INC.