Stool Softener description, usages, side effects, indications, overdosage, supplying and lots more!

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Stool Softener

Dispensing Solutions, Inc.
PSS World Medical, Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool Softener Laxative

Stool Softener Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours

Warnings

Ask a doctor before use if you

• have stomach pain, nausea or vomiting

• have a sudden change in bowel habits that persists over a period of 2 weeks

• are presently taking mineral oil

Stop use and ask a doctor if

• you need to use a laxative longer than 1 week

• you have rectal bleeding or fail to have a bowel movement. 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 and older: take 1-2 softgel daily until first bowel movement; 1 softgel daily thereafter, or as directed by doctor

• children under 12: consult a doctor

• do not exceed recommended dose

Stool Softener Other information

each softgel contains: sodium 5 mg. very low sodium

• store at 15°C-25°C(59° F-77° F)

• keep tightly closed

• product from USA or Canada

Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Inactive ingredients

FD and C red 40, gelatin, glycerin, edible ink, PEG, propylene glycol, sorbitol special, water. May also contain D and C yellow 10, FD and C yellow 6 (sunset yellow), mannitol.

Package Label

GERICARE

NDC 66336-0792-XX

NDC 66336-0792-94

Stool Softener

compare to active ingredient in colace

Docusate Sodium

120 Softgels

100 mg each

Stool Softener

Stool Softener

Docusate Sodium CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:66336-792(NDC:57896-401)
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
GELATIN
GLYCERIN
polyethylene glycol 400
propylene glycol
sorbitol
water
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
mannitol

Product Characteristics

Color Size Imprint Code Shape
red (reddish) 12 mm SCU1 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:66336-792-94 120 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2000-01-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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