Stool Softener Laxative by Family Dollar (FAMILY WELLNESS) DRUG FACTS

Stool Softener Laxative by

Drug Labeling and Warnings

Stool Softener Laxative by is a Otc medication manufactured, distributed, or labeled by Family Dollar (FAMILY WELLNESS). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STOOL SOFTENER LAXATIVE- docusate sodium, sennosides tablet 
Family Dollar (FAMILY WELLNESS)

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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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 older 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 30 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 phosphate dihydrate, FD&C red # 40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium benzoate, 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 OF COLACE®  2-IN-1*

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 or distributed by Avrio Health L.P., distributor of Colace® 2-IN-1.

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

500 VOLVO PARKWAY,

CHESAPEAKE, VA 23320

Product Label

Docusate Sodium 50 mg, Sennosides 8.6 mg

FAMILY WELLNESS Stool Softener with Laxative

STOOL SOFTENER LAXATIVE 
docusate sodium, sennosides tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55319-878
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)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
ColorredScoreno score
ShapeROUNDSize10mm
FlavorImprint Code TCL097
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55319-878-10100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/202012/31/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33406/30/202012/31/2025
Labeler - Family Dollar (FAMILY WELLNESS) (024472631)

Revised: 1/2023