Non-Habit Forming Stool Softener description, usages, side effects, indications, overdosage, supplying and lots more!

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Non-Habit Forming Stool Softener

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 100 mg

Purpose

Stool softener

Non-Habit Forming Stool Softener Uses

  • for 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 longer than 1 week, unless directed by a doctor 

Ask a doctor before use if

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 care 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 over 12 years of age  take 1 to 3 softgels preferably at bedtime
 children 6-12 years of age  take 1 softgel at bedtime
 children under 6 years  ask a doctor

Non-Habit Forming Stool Softener Other information

  • each softgel contains: sodium 6 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

COMPARE TO ACTIVE INGREDIENT IN COLACE®*

NON-HABIT FORMING

Stool Softener Laxative

Docusate Sodium USP, 100 mg

SOFTGEL CAPSULES

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

*Rugby Laboratories is not affiliated with the owner of the trademark Colace®.

Distributed by: Rugby Laboratories

31778 Enterprise Drive

Livonia, MI  48150

www.rugbylaboratories.com

Product Label

Non-Habit Forming Stool Softener
Rugby Stool Softener Laxative Softgel

Non-Habit Forming Stool Softener

DOCUSATE SODIUM CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0536-3756
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
POLYETHYLENE GLYCOLS
propylene glycol
water
sorbitol

Product Characteristics

Color Size Imprint Code Shape
ORANGE (orange) 13 mm P51 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0536-3756-01 100 in 1 BOTTLE
2 NDC:0536-3756-10 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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Be sure to consult your doctor before taking any medication!
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