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

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Stool Softener

The Kroger Co.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener laxative

Stool Softener Uses

  • for temporary relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 12 to 72 hours

Warnings

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks

Ask a doctor or pharmacist before use if you are

presently taking mineral oil.

Stop use and ask a doctor if

  • you have rectal bleeding or no bowel movement after using a laxative. These could be signs of a serious condition.
  • you need to use a laxative for more than 1 week

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. (1-800-222-1222)

Directions

  • take with a glass of water
 adults and children 12 years and over  take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses. 
 children 2 to under 12 years of age   take 1 softgel daily 
 children under 2 years  ask a doctor 

Stool Softener Other information

  • each softgel contains: sodium 7 mg
  • store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

edible ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, medium-chain triglycerides*, polyethylene glycol, propylene glycol*, purified water, sorbitan, sorbitol

*contains one or more of these ingredients

Questions or comments?

1-800-632-6900

Principal Display Panel

COMPARE TO the active ingredient of DULCOLAX® **See bottom panel

Stool Softener

Docusate Sodium,100 mg

GENTLE RELIEF

Gentle & Dependable Relief of Occasional Constipation

SOFTGELS

**Dulcolax® is a registered trademark of Boehringer Ingelheim Consumer Health Care Products, Ridgefield, CT 06877. Boehringer Ingelheim Consumer Health Care is not affiliated with The Kroger Co, or this product. 

DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202

www.kroger.com

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Product Label

Stool Softener
Kroger Stool Softener Softgel

Stool Softener

DOCUSATE SODIUM CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:30142-244
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM DOCUSATE 100 mg

Inactive Ingredients

Ingredient Name Strength
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
MEDIUM-CHAIN TRIGLYCERIDES
POLYETHYLENE GLYCOLS
propylene glycol
water
SORBITAN
sorbitol

Product Characteristics

Color Size Imprint Code Shape
ORANGE 12 mm P51;S77;SCU1 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 25 in 1 BOTTLE, PLASTIC
2 NDC:30142-244-25 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2013-12-30


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Be sure to consult your doctor before taking any medication!
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