Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 117c82a6-2063-566b-e054-00144ff88e88
Route
ORAL
Published
Effective Date 2013-09-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (100 mg)
Inactive Ingredients
D&c Red No. 33 Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycols Propylene Glycol Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: 51A Shape: oval Color: red Size: 5 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-08-26

Description

Docusate sodium 100 mg

Purpose

Stool softener


Medication Information

Purpose

Stool softener

Description

Docusate sodium 100 mg

Uses
  • relieves occasional constipation (irregularity)

  • generally produces bowel movement in 12 to 72 hours

Warnings


Directions
  • doses may be taken as a single daily dose or in divided doses

adults and children 12 years and over                        

take 1 to 3 softgels daily

children 2 to under 12 years of age

take 1 softgel daily

children under 2 years

ask a doctor

Questions?

Adverse drug event call (800) 687-0176

Do Not Use

if you are currently taking mineral oil, unless directed by a doctor

Other Information
  • each capsule contains sodium 6 mg
  • store at room temperature 15 o-30 oC (59 o-86 oF)
  • Tamper Evident: Do not use if imprinted safety seal under cap is broken or missing
Principal Display Panel

Blenheim Pharmacal, Inc.

NDC 10544-130-20

Docusate Sodium [Stool Softener] Softgel Capsules, 100mg

20 Softgel Capsules

Stop Use and Ask A Doctor If
  • you have rectal bleeding
  • you fail to have a bowel movement after use
  • you need to use a stool softener laxative for more than 1 week



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.

Active Ingredient (in Each Softgel)

Docusate sodium 100 mg

Ask A Doctor Before Use If You Have
  • stomach pain, nausea or vomiting

  • have noticed a sudden change in bowel habits that lasts over 2 weeks

Inactive Ingredients: D&c Red #33,edible Ink, Fd&c Red #40, Fd&c Yellow #6, Gelatin, Glycerin, Polyethylene Glycol, Propylene Glycol, Sorbitol Special



Structured Label Content

Uses
  • relieves occasional constipation (irregularity)

  • generally produces bowel movement in 12 to 72 hours

Purpose

Stool softener

Warnings


Directions
  • doses may be taken as a single daily dose or in divided doses

adults and children 12 years and over                        

take 1 to 3 softgels daily

children 2 to under 12 years of age

take 1 softgel daily

children under 2 years

ask a doctor

Questions?

Adverse drug event call (800) 687-0176

Do Not Use (Do not use -)

if you are currently taking mineral oil, unless directed by a doctor

Other Information (Other information)
  • each capsule contains sodium 6 mg
  • store at room temperature 15 o-30 oC (59 o-86 oF)
  • Tamper Evident: Do not use if imprinted safety seal under cap is broken or missing
Principal Display Panel

Blenheim Pharmacal, Inc.

NDC 10544-130-20

Docusate Sodium [Stool Softener] Softgel Capsules, 100mg

20 Softgel Capsules

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you have rectal bleeding
  • you fail to have a bowel movement after use
  • you need to use a stool softener laxative for more than 1 week



If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Docusate sodium 100 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • stomach pain, nausea or vomiting

  • have noticed a sudden change in bowel habits that lasts over 2 weeks

Inactive Ingredients: D&c Red #33,edible Ink, Fd&c Red #40, Fd&c Yellow #6, Gelatin, Glycerin, Polyethylene Glycol, Propylene Glycol, Sorbitol Special (Inactive ingredients: D&C red #33,Edible ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special)



Advanced Ingredient Data


Raw Label Data

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