STOOL SOFTENER GENTLE RELIEF description, usages, side effects, indications, overdosage, supplying and lots more!

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STOOL SOFTENER GENTLE RELIEF

PuraVation Pharmaceuticals Inc

STOOL SOFTENER GENTEL RELIEF (Docusate Sodium) capsule, liquid filled


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener

STOOL SOFTENER GENTLE RELIEF 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 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

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

take with a glass of water

Adults and children 12 years of age and over

take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses

Children 2 and under 12 years of age

take 1 softgel daily

children under 2 years of age

ask a doctor

STOOL SOFTENER GENTLE RELIEF Other information

  • each softgel contains: sodium 6 mg
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

FD&C Red # 40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, sorbitol special, purified water

Questions or comments? Call toll free: 1-800-833-6278

PRINCIPAL DISPLAY PANEL

STOOL SOFTENER

Gentle Relief

Provides safe, gentle relief of constipation

Docusate Sodium 100 mg

  • Softens stool
  • Provides gentle relief

100 SOFT FELS

Compare to the active ingredient in DULCOLAX® 

STOOL SOFTENER GENTLE RELIEF

STOOL SOFTENER GENTLE RELIEF

DOCUSATE SODIUM CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:76270-101
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
water
sorbitol

Product Characteristics

Color Size Imprint Code Shape
red 13 mm PC1 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 100 in 1 BOTTLE, PLASTIC
2 250 in 1 BOTTLE, PLASTIC
3 NDC:76270-101-27 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2013-04-15


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Be sure to consult your doctor before taking any medication!
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