Docusate Sodium, Usp

Docusate Sodium, Usp
SPL v3
SPL
SPL Set ID 0c66642c-82cb-42cd-82bb-5f95852cc5d1
Route
ORAL
Published
Effective Date 2020-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (250 mg)
Inactive Ingredients
Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin, Unspecified Glycerin Polyethylene Glycol 1000 Propylene Glycol Water Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: NV12 Shape: oval Color: red Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2000-05-01 Until 2027-10-31

Description

Docusate Sodium 250 mg

Purpose

Stool Softener


Medication Information

Purpose

Stool Softener

Description

Docusate Sodium 250 mg

Uses
  • For the relief of occasional constipation.
  • Helps to prevent dry, hard stools.
  • This product generally produces a bowel movement within 12 to 72 hours.
Questions

Call 1 (800) 682-9862

Directions

Adults and Children over 12 years of age

Take orally 1 softgel preferably at bedtime for

2-3 days or until bowel movements are normal, or as directed by a doctor.

Children under 12 years of age

Do not use this product for children under 12 years of age, unless directed by a doctor.

Other Information
  • Each softgel contains 13 mg of Sodium.
  • Store at room temperature between 15°C to 30°C (59°F to 86°F).
  • Do not use if printed seal under cap is broken or missing.
  • For identification purposes, each softgel will have an imprint that reads NV12.
Inactive Ingredients

FD&C Red #40, FD&C Yellow #6, Gelatin, Glycerin, Ink (Edible), Polyethylene Glycol, Propylene Glycol, Purified Water, Sorbitol.

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 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 two weeks.

Stop Use and Ask A Doctor

if you have rectal bleeding or you fail to have a bowel movement after use.

If Pregnant Or Breast Feeding,

ask a healthcare 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 250 mg

Package/label Principal Display Panel

NDC 54629-601-01

Life-Line®

Docusate Sodium, USP

Stool Softener

250 mg Each

100 Softgels

Manufactured and Distributed by

National Vitamin Company

Casa Grande, AZ 85122

Bottle Label

Structured Label Content

Uses
  • For the relief of occasional constipation.
  • Helps to prevent dry, hard stools.
  • This product generally produces a bowel movement within 12 to 72 hours.
Purpose

Stool Softener

Questions

Call 1 (800) 682-9862

Directions

Adults and Children over 12 years of age

Take orally 1 softgel preferably at bedtime for

2-3 days or until bowel movements are normal, or as directed by a doctor.

Children under 12 years of age

Do not use this product for children under 12 years of age, unless directed by a doctor.

Other Information
  • Each softgel contains 13 mg of Sodium.
  • Store at room temperature between 15°C to 30°C (59°F to 86°F).
  • Do not use if printed seal under cap is broken or missing.
  • For identification purposes, each softgel will have an imprint that reads NV12.
Inactive Ingredients

FD&C Red #40, FD&C Yellow #6, Gelatin, Glycerin, Ink (Edible), Polyethylene Glycol, Propylene Glycol, Purified Water, Sorbitol.

Warnings Do Not Use: (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 one week unless directed by a doctor.
Ask A Doctor Before Use (Ask a doctor before use)

if you notice a sudden change in bowel habits that persists over a period of two weeks.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if you have rectal bleeding or you fail to have a bowel movement after use.

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

ask a healthcare 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 250 mg

Package/label Principal Display Panel (Package/Label Principal Display Panel)

NDC 54629-601-01

Life-Line®

Docusate Sodium, USP

Stool Softener

250 mg Each

100 Softgels

Manufactured and Distributed by

National Vitamin Company

Casa Grande, AZ 85122

Bottle Label

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)