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.

----------

Drug Facts

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Purpose

Stool softener

Stimulant laxative

Uses

  • for overnight relief from occasional constipation (irregularity)
  • generally produces bowel movement in 6 to12 hours

Warnings

Do not use

  • laxative products for longer than 1 week unless directed by a doctor
  • if you are now taking mineral oil, unless directed 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 may indicate 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

  • Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.
adults and children 12 years and oldertake 2-4 tablets daily 
children 6 to under 12 years of agetake 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: calcium 20 mg
  • each tablet contains: sodium 6 mg VERY LOW SODIUM
  • store at 25ºC (77ºF); excursions permitted between 15-30ºC(59-86ºF)

Inactive ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #2, FD&C red #40, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silcon dioxide, stearic acid, talc, titanium dioxide

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredients in Peri-Colace®

Stool Softener 

+ Stimulant Laxative

Docusate sodium, 50 mg

Stool softener

Sennosides 8.6 mg

Stimulant laxative

For overnight relief of occasional constipation

  • Effective
  • Reliable
  • Comfortable

TABLETS

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

†This product is not manufactured or distributed by Purdue Products LP., distributor of Peri-Colace®.

Manufactured by:

Avema Pharma Solutions

10400 NW 29th Terrace

Miami, FL 33172

Product Label

Docusate sodium 50 mg, Sennosides 8.6 mg

Stool Softener red tablet

STOOL SOFTENER  PLUS STIMULANT LAXATIVE
docusate sodium and sennosides tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63548-0484
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
Product Characteristics
ColorredScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 0806;AV
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63548-0484-11000 in 1 BOTTLE; Type 0: Not a Combination Product01/02/201001/02/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/02/201001/02/2024
Labeler - PLD Acquisitions LLC DBA Avéma Pharma Solutions (804087794)

Revised: 2/2023
Document Id: e0f9b183-773f-4e79-8ab2-e67ce423f96b
Set id: 9279c355-39bb-4f35-aa95-a99571de640f
Version: 3
Effective Time: 20230209
 
PLD Acquisitions LLC DBA Avéma Pharma Solutions