STOOL SOFTENER- docusate sodium and sennosides tablet, coated 
PLD Acquisitions LLC DBA Avéma Pharma Solutions

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Drug Facts

Active ingredients (in each tablet)

Docusate Sodium 50 mg*

Sennosides 8.6 mg**

Purpose

*Stool softener

**Stimulant laxative

Uses

relief of occasional constipation (irregularity). This product generally produces a bowel movement within 6 to 12 hours.

Warnings

Ask a doctor before use if you have

  • stomach
  • pain
  • nausea
  • vomiting
  • a sudden change in bowel habits that lasts over a period of 2 weeks

ask a doctor or pharmacist before use if

Ask a doctor or pharmacist before use if you are presently taking mineral oil.

Stop use and ask a doctor if

  • you need to use a laxative for more than 1 week
  • you have no bowel movement or have rectal bleeding. These may be signs of a serious condition.

if pregnant or breast-feeding

If pregnant or breast-feeding, ask a health care professional before use.

keep out of reach of children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • doses may be taken as a single dose or in divided doses preferably in the evening
 adults and children 12 years of age and older take 2-4 tablets daily
 children 6 to under 12 years of age take 1-2 tablets daily
 children 2 to 6 years of age take up to 1 tablet daily
 children under 2 years of age ask a doctor

Other information

  • each tablet contains: sodium 6 mg/tablet VERY LOW SODIUM
  • each tablet contains: calcium 20 mg/tablet
  • store at 15°-30°C (59°-86°F), protect from excessive moisture
  • do not use if imprinted safety seal under cap is broken or missing
  • *This product is not manufactured or distributed by Purdue Pharma L.P., owner of the registered trademark Peri-Colace®.

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C Red #40 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, sodium benzoate, stearic acid, and titanium dioxide. May also contain: ethanol, FD&C Blue # 2 Aluminum Lake, maltodextrin, mineral oil, Opadry ll Red, pregelatinized starch, silicon dioxide 50s.

Package/Label Principal Display Panel

Stool Softener Plus Stimulant Laxative 100 Tablets Packaging Label

NDC 63548-4000-*1

Compare to the active ingredients of Peri-Colace®*

STOOL SOFTENER PLUS STIMULANT LAXATIVE

DOCUSATE SODIUM, 50 MG

PLUS SENNOSIDES, 8.6 MG

For Relief of Occasional Constipation

100 TABLETS

STOOL SOFTENER 
docusate sodium and sennosides tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63548-4000
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)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize4mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63548-4000-1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/02/201002/28/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER01/02/201002/28/2017
Labeler - PLD Acquisitions LLC DBA Avéma Pharma Solutions (804087794)

Revised: 3/2017
 
PLD Acquisitions LLC DBA Avéma Pharma Solutions