DOCUSATE SODIUM description, usages, side effects, indications, overdosage, supplying and lots more!

DOCUSATE SODIUM

DIRECT RX

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
DOCUSATE SODIUM

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 100 mg

OTC - PURPOSE SECTION

Stool softener

INDICATIONS & USAGE SECTION

  • for prevention of dry, hard stools
  • for relief of occasional constipation

This product generally produces a bowel movement within 12 to 72 hours.

WARNINGS SECTION

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.

DOSAGE & ADMINISTRATION SECTION

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

Other information

  • each softgel contains: sodium 6 mg
  • store between 15º-30ºC (59º-86ºF)

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENT SECTION

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

DOCUSATE SODIUM

DOCUSATE SODIUM CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:61919-459(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 13 mm P51 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61919-459-71 100 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2014-01-01


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Be sure to consult your doctor before taking any medication!
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