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Stool Softener with Stimulant Laxative

Medically reviewed on Aug 1, 2017

Dosage form: tablet
Ingredients: DOCUSATE SODIUM 50mg, SENNOSIDES 8.6mg
Labeler: Family Dollar (FAMILY WELLNESS)
NDC Code: 55319-084

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 to 12 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 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: 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

carnauba wax*, croscarmellose sodium, dibasic calcium pjosphate dihydrate, FD&C blue #2 aluminum lake, FD&C red # 40 aluminum lake, hypromellose*, magnesium stearate, maltodextrin*, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol*, silicon dioxide, sodium benzoate*, stearic acid, talc*, titanium dioxide

*contains one or more of these ingredients

Questions or comments?

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

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENTS OF PERI-COLACE®†

Stool Softener

With Stimulant Laxative

Docusate sodium 50 mg

Sennosides 8.6 mg

Relieves Constipation

TABLETS

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

†This product is not manufactured ir distributed by Purdue Products L.P distributor of Peri-Colace®.

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

10611 MONROE RD., MATTHEWS, NC 28105

Product Label

FAMILY WELLNESS Stool Softener

STOOL SOFTENER WITH STIMULANT LAXATIVE 
docusate sodium, sennosides tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-084
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM50 mg
SENNOSIDES (SENNOSIDES) SENNOSIDES8.6 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
CROSCARMELLOSE SODIUM 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
SODIUM BENZOATE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
SILICON DIOXIDE 
ALUMINUM OXIDE 
FD&C BLUE NO. 2 
FD&C RED NO. 40 
POLYVINYL ALCOHOL, UNSPECIFIED 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize10mm
FlavorImprint CodeTCL097;0806;AV;S44
Contains    
Packaging
#Item CodePackage Description
1NDC:55319-084-01100 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33411/30/2015
Labeler - Family Dollar (FAMILY WELLNESS) (024472631)

 
Family Dollar (FAMILY WELLNESS)

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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