EXTRA STRENGTH STOOL SOFTENER LAXATIVE description, usages, side effects, indications, overdosage, supplying and lots more!

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EXTRA STRENGTH STOOL SOFTENER LAXATIVE

Cardinal Health

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient (in each softgel)

Docusate Sodium 250 mg

Purpose

Stool softener

EXTRA STRENGTH STOOL SOFTENER LAXATIVE Uses

  • for the prevention of dry, hard stools
  • for relief of occasional constipation
  • this product generally produces a bowel movement within 12 to 72 hours

Warnings

Do not use

  • if you are currently taking mineral oil, unless directed by a doctor
  • when abdominal pain, nausea, or vomiting are present
  • for more than 1 week, unless directed by a doctor

Ask a doctor before use if

you notice a sudden change in bowel habits that persists over a period of 2 weeks.

Stop use and ask a doctor if

  • you have rectal bleeding
  • you fail to have a bowel movement after use

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.

This package is intended for in-patient institutional use only.

Directions

  • adults and children 12 years of age and over: take1 softgel daily or as directed by a doctor
  • children under 12 years of age: take as directed by a doctor

EXTRA STRENGTH STOOL SOFTENER LAXATIVE Other information

each softgel contains: sodium 15 mg

  • store between 15º-30ºC (59º-86ºF)
  • See window for lot number and expiration date

Inactive Ingredients

edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special

Questions or comments?

1-800-645-2158

Extra Strength Stool Softener Laxative
Docusate Sodium USP, 250 mg

SOFTGEL CAPSULES

Distributed by: Rugby Laboratories

31778 Enterprise Drive

Livonia, MI  48150
www.rugbylaboratories.com

Rugby is trademark of its respective owner.

Repackaged by: Cardinal Health

Zanesville, OH 43701

LUC4600029-10114

LUC4600029-20114

Principal Display Panel

Stool Softener

(docusate sodium USP)

250 mg

EXTRA STRENGTH STOOL SOFTENER LAXATIVE

Stool Softener

(docusate sodium USP)

250 mg

100 Softgel Capsules

EXTRA STRENGTH STOOL SOFTENER LAXATIVE

Stool Softener

Laxative

Docusate Sodium USP, 250 mg

10 SOFTGEL CAPSULES

EXTRA STRENGTH STOOL SOFTENER LAXATIVE

 

EXTRA STRENGTH STOOL SOFTENER LAXATIVE

DOCUSATE SODIUM CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55154-6812(NDC:0536-3757)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM DOCUSATE 250 mg

Inactive Ingredients

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

Product Characteristics

Color Size Imprint Code Shape
orange (orange) 20 mm P20 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55154-6812-6 1 in 1 POUCH
2 1 in 1 POUCH
3 NDC:55154-6812-0 10 in 1 BAG

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2012-03-29


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Be sure to consult your doctor before taking any medication!
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