docusate sodium - stool softener laxative

docusate sodium - stool softener laxative
SPL v3
SPL
SPL Set ID 34e06b05-64a5-4b3e-af38-cdcd7c1d521b
Route
oral
Published
Effective Date 2024-08-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
docusate (250 mg)
Inactive Ingredients
gelatin, unspecified glycerin polyethylene glycol, unspecified crospovidone (120 .mu.m) propylene glycol water sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: C250 Shape: oval Color: white Size: 12 mm Score: 1
Marketing Status
otc monograph drug active Since 2024-08-05

Purpose

Stool softener

Description

Docusate Sodium 250 mg


Medication Information

Warnings

Do not useif you are presently taking mineral oil, unless told to do so by a doctor.

Ask a doctor before use if you have

  • Stomach pain
  • Nausea
  • Vomiting
  • Noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if

  • you have rectal bleeding or fail to have a bowel movement after use of a laxative.

    These can be signs of a serious condition
  • you need to use a stool softner laxative for more than 1 week

If pregnant or breast-feeding, ask a health care professional before use.

Uses
  • relieves occasional constipation (irregularity)

    • generally produces a bowel movement within 12 to 72 hours.
Purpose

Stool softener

Directions

adults and children 12 years of age and older

take 1 softgel daily or as directed by a doctor.

children under 12 years of age

ask a doctor

Other Information
  • each softgel contains:sodium 15mg
  • store at 20-25°C (68-77°F).
  • Keep carton for full product information
Inactive Ingredients

gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol. Softgels are imprinted with edible, dye-free ink.

Description

Docusate Sodium 250 mg

Principal Display Panel

EXTRA STRENGTH

#1 DOCTOR RECOMMENDED

Stool Softner Brand

COLACE

Docusate Sodium, 250mg

EXTRA STRENGTH

Stool Softner

√Gentle & Effective

√Relieves Constipation

√Cramp & Stimulant-Free

√Dye & Preservative-Free

60 Clear Soft Gels

Retain this carton for important information.

Dis. By: Atlantis Consumer Healthcare Inc.

Bridgewater, NJ 08807 USA

Questions? 1-833-288-2684

©2024 Atlantis Consumer Healthcare Inc.

Colace is a registered trademark of Atlantis Consumer Healthcare Inc.

A0824

Section 50565-1

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately.

Questions? 

1-833-288-2684

Active Ingredient (in Each Softgel)

Docusate Sodium 250 mg


Structured Label Content

Warnings

Do not useif you are presently taking mineral oil, unless told to do so by a doctor.

Ask a doctor before use if you have

  • Stomach pain
  • Nausea
  • Vomiting
  • Noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if

  • you have rectal bleeding or fail to have a bowel movement after use of a laxative.

    These can be signs of a serious condition
  • you need to use a stool softner laxative for more than 1 week

If pregnant or breast-feeding, ask a health care professional before use.

Uses
  • relieves occasional constipation (irregularity)

    • generally produces a bowel movement within 12 to 72 hours.
Purpose

Stool softener

Directions

adults and children 12 years of age and older

take 1 softgel daily or as directed by a doctor.

children under 12 years of age

ask a doctor

Other Information (Other information)
  • each softgel contains:sodium 15mg
  • store at 20-25°C (68-77°F).
  • Keep carton for full product information
Inactive Ingredients (Inactive ingredients)

gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol. Softgels are imprinted with edible, dye-free ink.

Principal Display Panel

EXTRA STRENGTH

#1 DOCTOR RECOMMENDED

Stool Softner Brand

COLACE

Docusate Sodium, 250mg

EXTRA STRENGTH

Stool Softner

√Gentle & Effective

√Relieves Constipation

√Cramp & Stimulant-Free

√Dye & Preservative-Free

60 Clear Soft Gels

Retain this carton for important information.

Dis. By: Atlantis Consumer Healthcare Inc.

Bridgewater, NJ 08807 USA

Questions? 1-833-288-2684

©2024 Atlantis Consumer Healthcare Inc.

Colace is a registered trademark of Atlantis Consumer Healthcare Inc.

A0824

Section 50565-1 (50565-1)

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately.

Questions? 

1-833-288-2684

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

Docusate Sodium 250 mg


Advanced Ingredient Data


Raw Label Data

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