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

card label

Principal Display Panel

Stool Softener

Docusate Sodium

100 mg softgels

QTY 28

lidding label

Package Label

Stool Softener

Docusate Sodium

100 mg each

QTY 30 Softgels

Blister label

Card Label

Stool Softener

Docusate Sodium

100 mg each

card label
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 DEA Schedule     
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)  
GELATIN (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     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55154-1876-9 30 in 1 BLISTER PACK; Type 0: Not a Combination Product
2 NDC:55154-1876-3 28 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 01/01/2000
Labeler - Cardinal Health (188557102)
Registrant - Geri-Care Pharmaceutical Corp (611196254)
Establishment
Name Address ID/FEI Business Operations
Cardinal Health 188557102 REPACK(55154-1876)

Revised: 1/2015
Document Id: 698749ea-cb79-4310-a77e-1840c73f22d1
Set id: 29f615e2-b624-4295-81ba-6d4bec2fc7b5
Version: 5
Effective Time: 20150107
 
Cardinal Health