Stool Softener description, usages, side effects, indications, overdosage, supplying and lots more!

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Stool Softener

Care One (American Sales Company)
P and L Development of New York Corporation

DRUG FACTS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Purpose

Stool softener

Stimulant laxative

Stool Softener 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

Stool Softener
Stool softener plus stimulant laxative tablets

Stool Softener

docusate sodium and sennosides TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:41520-022
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM DOCUSATE 50 mg
SENNOSIDES SENNOSIDES 8.6 mg

Inactive Ingredients

Ingredient Name Strength
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

Color Size Imprint Code Shape
RED 10 mm TCL97;SS2;S44 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 100 in 1 BOTTLE
2 NDC:41520-022-01 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2013-03-01


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Be sure to consult your doctor before taking any medication!
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