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

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EXTRA STRENGTH STOOL SOFTENER LAXATIVE

Rugby Laboratories Inc
P and L Development of New York Corporation

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.

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)

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

Principal Display Panel

Extra Strength Stool Softener Laxative
Docusate Sodium USP, 250 mg

SOFTGEL

CAPSULES

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

Distributed by: Rugby Laboratories

31778 Enterprise Drive

Livonia, MI  48150
www.rugbylaboratories.com

Package Label

EXTRA STRENGTH STOOL SOFTENER LAXATIVE

Rugby Extra Strength Sool Softener Laxative Softgel
 

EXTRA STRENGTH STOOL SOFTENER LAXATIVE

DOCUSATE SODIUM CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) 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:0536-3757-01 100 in 1 BOTTLE
2 NDC:0536-3757-10 1000 in 1 BOTTLE

Marketing Information

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


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