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

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EXTRA STRENGTH STOOL SOFTENER LAXATIVE

Dispensing Solutions, Inc.
PSS World Medical, Inc.

Docusate Sodium ES


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient (in each softgel)

Docusate Sodium 250mg

Purpose

Stool softener

EXTRA STRENGTH STOOL SOFTENER LAXATIVE Uses

  • Relieves occasional constipation.
  • Generally produces bowel movement within 12 to72 hours.

Warnings - Do not use

  • for longer than one week
  • if you are taking mineral oil
  • when abdominal pain, nausea, or vomiting are present

Ask a doctor before use if

you have a sudden change in bowel habits that lasts over two weeks

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop use and ask a doctor if

  • you experience rectal bleeding
  • you fail to have a bowel movement after using this product

These may indicate a serious condition.

If pregnant or breastfeeding

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 over 12 years and over:1 capsule once daily
  • children under 12 years: ask a doctor

EXTRA STRENGTH STOOL SOFTENER LAXATIVE Other information

  • store at controlled room temperature 15 - 30 degrees C (59-86 degrees F)

Each capsule contains sodium 15mg

Inactive Ingredients

edible white ink, FDandC Red No. 40, FDandC Yellow No. 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified wter, sorbitol special.

Questions or comments?

Call 1-800-645-2158, 9am - 5am ET Monday - Friday

Product Labeling

Rugby Extra Strength Stool Softener Laxative
Docusate Sodium USP, 250mg

Mfd for: Rugby Laboratories, Inc
Duluth Georgia 30097
www.rugbylaboratories.com

Package Label

NDC 66336-0010-XX

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:66336-010(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:66336-010-20 20 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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