STOOL SOFTENER PLUS STIMULANT LAXATIVE- docusate sodium and sennosides tablet 
Avema Pharma Solutions

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.

----------

Stool Softener plus Stimulant Laxative

Active Ingredients (in each tablet)

Docusate Sodium 50 mg
Sennosides 8.6 mg

Purpose

Stool softener
Stimulant Laxative

Uses

Warnings
Do not use

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

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

Take only by mouth. Doses may be taken as a single daily does or in divided doses.

Other information

Inactive Ingredients

carnauba wax, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C Blue #2 Aluminum Lake*, FD&C Red #40 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol*, silicon dioxide, sodium benzoate, stearic acid, talc*, and titanium dioxide

*contains one or more of these ingredients

Questions or comments?

call toll free 1-877-753-3935 Monday - Friday 9AM - 5PM EST

Product Label

Comapre to the active ingredients in Peri- colace®

Stool Softener plus stimulant laxative

Docusate Sodium 50 mg
Sennosides, 8.6 mg

Distributed by:

PL Developments

200 Hicks street

Westbury, NY 11590

Product Label

 PLD Miami Stool softener with stimulant laxative 100 count

Stool Softener with stimulant laxative

STOOL SOFTENER PLUS STIMULANT LAXATIVE 
docusate sodium and sennosides tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63548-0056
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 50 mg
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES 8.6 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color RED Score no score
Shape ROUND Size 10mm
Flavor Imprint Code TCL97;SS2;S44
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63548-0056-1 100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part334 05/18/2011
Labeler - Avema Pharma Solutions (804087794)

Revised: 8/2012
Document Id: 627333c2-4233-4a95-bd93-53d1257ef07e
Set id: 2d2cf9c9-63be-43c2-a103-bb48f1fec837
Version: 4
Effective Time: 20120803
 
Avema Pharma Solutions