Your browser does not support JavaScript! STOOL SOFTENER AND STIMULANT LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET [CARE ONE (AMERICAN SALES COMPANY)]
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STOOL SOFTENER AND STIMULANT LAXATIVE (docusate sodium and sennosides) tablet
[Care One (American Sales Company)]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

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 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 could be signs of 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 15º-30ºC (59º-86ºF), protect from excessive moisture

Inactive ingredients

carnauba wax*, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake*, hypromellose, magnesium stearate, maltodextrin*, microcrystalline cellulose, polydextrose*, polyethylene glycol*, purified water*, sodium benzoate*, stearic acid, talc*, titanium dioxide, triglycerides*

*contains one or more of these ingredients

Questions or comments?

Call toll free 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

Sennosides, 8.6 mg

A GENTLE, PREDICTABLE LAXATIVE

TABLETS

DISTRIBUTED BY FOODHOLD U.S.A., LLC

LANDOVER, MD  20785

1-877-846-9949

©2013 S&S Brands LLC

Quality guaranteed or your money back.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED 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 L.P., owner of the registered trademark Peri-Colace®

Product Label

Care One

Stool softener plus stimulant laxative tablets

STOOL SOFTENER  AND STIMULANT LAXATIVE
docusate sodium and sennosides tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41520-022
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 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
WATER 
SILICON DIOXIDE 
SODIUM BENZOATE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
ALUMINUM OXIDE 
POLYDEXTROSE 
C10-18 TRIGLYCERIDES 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize10mm
FlavorImprint Code TCL97;SS2;S44
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-022-011 in 1 BOX
1100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33403/01/2013
Labeler - Care One (American Sales Company) (809183973)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 8/2013
 
Care One (American Sales Company)

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