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Fleet

C.B. Fleet Company, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient

(in each softgel)

Docusate Sodium 100 mg..............Stool Softener

Fleet Uses

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

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.

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 one 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 symptoms may indicate a serious condition.

Directions

Single Daily Dosage

adults and children 12 years and over
1 - 3 softgels
children 2 to under 12 years
1 softgel
children under 2 years
ask a doctor

Other Information

  • each softgel contains: sodium 5 mg
  • this product generally produces a bowel movement within 12 to 72 hours
  • mouth of bottle sealed for your safety. If foil impirinted "SEALED FOR YOUR PROTECTION" is broken or missing, do not use

Inactive Ingredients

edible white ink, FDandC red 40, FDandC yellow 6, gelatin, glycerin, mannitol, polyethylene glycol, polysorbate, propylene glycol, purified water and sorbitol

Questions?

1-866-255-6960 or www.fleetlabs.com

Fleet

Fleet

Docusate Sodium CAPSULE, GELATIN COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0132-0751
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 YELLOW NO. 6
FD&C RED NO. 40
GELATIN
GLYCERIN
mannitol
polyethylene glycol 400
propylene glycol
water
sorbitol
POLYSORBATE 20

Product Characteristics

Color Size Imprint Code Shape
red (Clear, Bright Red) 5 mm P51 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0132-0751-60 60 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2002-06-30


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Be sure to consult your doctor before taking any medication!
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