TOPCARE STOOL SOFTENER- docusate sodium capsule, liquid filled

Topcare Stool Softener by

Drug Labeling and Warnings

Topcare Stool Softener by is a Otc medication manufactured, distributed, or labeled by TopCo Associates, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(s)

Docusate sodium 100mg

Purpose

Stool softener

Use(s)

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

Warnings

Do not use

• if you are presently taking mineral oil, unless 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 a period of 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 stool softener laxative for more than 1 week
  

Pregnancy/Breastfeeding

ask a health professional before use.

Keep out of reach of children

In case of accidental overdose, get medical help or contact a Poison Control Center 
(1-800-222-1222) 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 capsule contains: sodium 5mg
• VERY LOW SODIUM
  
  

Storage

• store 25°C (77°F) excursions permitted between 15°– 30°C (59°–86°F)
  

Inactive ingredients

Black edible ink, citric acid, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special

Questions

Call 1-888-952-0050 Monday through Friday 9am-5pm

Principal Display Panel

Stool Softener

Stool Softener

INGREDIENTS AND APPEARANCE

TOPCARE STOOL SOFTENER 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76162-006
Route of Administration	ORAL

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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	red, white	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	PC18
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76162-006-60	1 in 1 CARTON	04/10/2015
1		60 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 76162-006-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/10/2015
3	NDC: 76162-006-81	400 in 1 BOTTLE; Type 0: Not a Combination Product	04/10/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	04/10/2015

Labeler - TopCo Associates, LLC (006935977)