STOOL SOFTENER PLUS STIMULANT LAXATIVE- docusate sodium and sennosides tablet 
PLD Acquisitions LLC DBA Avéma 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.

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Stool Softener plus Stimulant Laxative

Active Ingredients (in each tablet)

Docusate Sodium 50 mg
Sennosides 8.6 mg

Purpose

Stool softener
Stimulant Laxative

Uses

  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement within 6 to 12hours.

Warnings
Do not use

  • laxative products for longer than 1 week unless told to do so by a doctor.
  • 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 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.

  • adults and children 12 years and over: take 2-4 tablets daily
  • children 6 to under 12 years of age: take 1-2 tablets daily
  • children 2 to under 6 years of age: take up to 1 tablet daily
  • children under 2: ask a doctor

Other information

  • each tablet contains:sodium 6mg/tablet VERY LOW SODIUM
  • each tablet contains: calcium 20mg/tablets
  • store at 15 - 30 degrees C (59-86 degrees F), protect from excessive moisture
  • **This product is not manufactured or distributed by Purdue Products, LP, owner of the registered trademark Peri Colace®.

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:63548-0056
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.6 mg
Inactive Ingredients
Ingredient NameStrength
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, UNSPECIFIED (UNII: 532B59J990)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize10mm
FlavorImprint Code TCL97;SS2;S44
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63548-0056-1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/18/201102/28/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33405/18/201102/28/2017
Labeler - PLD Acquisitions LLC DBA Avéma Pharma Solutions (804087794)

Revised: 3/2017
Document Id: b69dc73d-9ded-4226-988b-05f31ccc9b66
Set id: 2d2cf9c9-63be-43c2-a103-bb48f1fec837
Version: 5
Effective Time: 20170329
 
PLD Acquisitions LLC DBA Avéma Pharma Solutions