STOOL SOFTENER- docusate sodium capsule, liquid filled
Cardinal Health

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool Softener Laxative

Uses

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

Warnings

Ask a doctor before use if you

• have stomach pain, nausea or vomiting

• have a sudden change in bowel habits that persists over a period of 2 weeks

• are presently taking mineral oil

Stop use and ask a doctor if

• you need to use a laxative longer than 1 week

• you have rectal bleeding or fail to have a bowel movement. These

could be signs of a serious condition.

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.

Directions

• adults and children 12 years and older: take 1-2 softgels daily until first bowel movement; 1 softgel daily thereafter, or as directed by doctor

• children under 12: consult a doctor

• do not exceed recommended dose

Other information

• each softgel contains: sodium 5 mg. very low sodium

• store at 15°C-25°C(59° F-77° F)

• keep tightly closed

• product from USA or Canada

• Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Inactive ingredients

FD and C red #40, gelatin, glycerin, edible ink, PEG, propylene glycol, sorbitol special, water. May also contain D and C yellow #10, FD and C yellow #6 (sunset yellow), mannitol.

Compare to active ingredient in ColaceR*

*This product is not manufactured or distributed by the owner of the registered trademark ColaceR.

DIST. BY: GERI-CARE PHARMACUETICALS CORP.

1650 63rd Street, Brooklyn, NY 11204

REV 0112

Cardinal Health

Zanesville, OH 43701

IT48469450613

Principal Display Panel

Stool Softener

Docusate Sodium

100 mg Softgels

Principal Display Panel

Stool Softener

Docusate Sodium

100 mg softgels

QTY 28

Package Label

Stool Softener

Docusate Sodium

100 mg each

QTY 30 Softgels

Card Label

Stool Softener

Docusate Sodium

100 mg each

STOOL SOFTENER
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55154-1876(NDC:57896-401)
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 RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MANNITOL (UNII: 3OWL53L36A)

Product Characteristics
Color	red (reddish)	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	SCU1
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55154-1876-9	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	01/01/2000	08/15/2015
2	NDC:55154-1876-3	28 in 1 BLISTER PACK; Type 0: Not a Combination Product	01/01/2000	07/15/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	01/01/2000	08/15/2015

Labeler - Cardinal Health (188557102)

Registrant - Geri-Care Pharmaceutical Corp (611196254)

Name	Address	ID/FEI	Business Operations
Establishment
Cardinal Health		188557102	REPACK(55154-1876)

Revised: 4/2017

Document Id: 652595d2-d594-4cd1-b02e-ed3690b69642

Set id: 29f615e2-b624-4295-81ba-6d4bec2fc7b5

Version: 6

Effective Time: 20170407

Cardinal Health