STOOL SOFTENER

STOOL SOFTENER

Drug Labeling and Warnings

Drug Details

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STOOL SOFTENER- docusate sodium and sennosides capsule, gelatin coated 
CVS

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

DRUG FACTS

Active ingredients (in each softgel)Purpose
Docusate sodium 50 mg  Stool softener
 Sennosides 8.6 mg Stimulant Laxative

Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6-12 hours

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 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 of age or over take 2-4 softgels daily
 children 6 to under 12 years of age       take 1-2 softgels daily
 children 2 to under 6 years of age    take upto 1 softgel daily
 children under 2 ask a doctor

Other information

  • each softgel contains: calcium 2 mg and sodium 3 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • Keep tightly closed

Inactive ingredients

Aerosil, beeswax, FD&C Red No.40, gelatin, glycerin, light liquid paraffin, povidone (PVP K-30), purified water, sodium carboxymethylcellulose, sorbitol solution, soya lecithin, titanium dioxide

Questions?

Call 1-888-333-9792 Monday-Friday 9AM-5PM EST

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - 60 Capsule Bottle Carton

♥CVSHealth™

Compare to the active
ingredients in Peri-Colace®*

Liquid Filled Softgels

NDC: 69842-319-60

Stool Softener
DOCUSATE SODIUM, 50 mg
SENNOSIDES, 8.6 mg
Plus stimulant laxative

Package Contains One Bottle

60 SOFTGELS

Actual Size

image description

STOOL SOFTENER 
docusate sodium and sennosides capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69842-319
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
POVIDONE K30 (UNII: U725QWY32X)  
WATER (UNII: 059QF0KO0R)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SORBITOL (UNII: 506T60A25R)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorred (OPAQUE) Scoreno score
ShapeCAPSULE (SOFTGEL) Size12mm
FlavorImprint Code 584
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69842-319-601 in 1 CARTON03/15/2018
160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/15/2018
Labeler - CVS (062312574)
Registrant - SPIRIT PHARMACEUTICALS LLC (179621011)
Establishment
NameAddressID/FEIBusiness Operations
MEDGEL PRIVATE LIMITED677385498manufacture(69842-319)

Revised: 12/2019
 
CVS


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