docusate sodium, usp 100mg

docusate sodium, usp 100mg
SPL v2
SPL
SPL Set ID 7684b17d-ab3f-4202-ba75-7d0603c63e92
Route
oral
Published
Effective Date 2012-08-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
docusate (100 mg)
Inactive Ingredients
fd&c red no. 40 fd&c yellow no. 6 gelatin hypromelloses propylene glycol sorbitol titanium dioxide water glycerin

Identifiers & Packaging

Pill Appearance
Imprint: V100 Shape: oval Color: red Size: 5 mm Score: 1
Marketing Status
otc monograph not final active Since 2013-04-01

Purpose

Stool softener laxative

Description

(in each softgel) Docusate Sodium 100 mg


Medication Information

Warnings

Ask a doctor before use if you have:

  • stomach pain, nausea or vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks

Ask a doctor or pharmacist before use if you are presently taking mineral oil.

Stop use and ask a doctor if:

  • you have rectal bleeding or no bowel movement after using this product. This could be signs of a serious condition.
  • you need to use laxative for more than 1 week.

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

Uses
  • for temporary relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 12 to 72 hours
Purpose

Stool softener laxative

Directions

Take with glass of water

adults and children 12 years and over:

  • 1 to 3 liquid gels daily. This dose may be taken as single daily dose or in divided doses.

    Children under 12 years of age:

  • 1 liquid gel daily

Children under 2 years of age

Ask a doctor

Other Information
  • store at 15-30 °C (59-86 °F)
  • protect from excessive humidity
  • do not use this product if the safety seal under the cap is torn or missing
Inactive Ingredients

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

Description

(in each softgel) Docusate Sodium 100 mg

Active Ingredient

(in each softgel)

Docusate Sodium 100 mg

Questions Or Comments

Call 1-855-314-1850

Keep Out of Reach of Children.

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

Package Label.principal Display Panel

NDC: 076168-069-05 – 25 COUNT


Structured Label Content

Warnings

Ask a doctor before use if you have:

  • stomach pain, nausea or vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks

Ask a doctor or pharmacist before use if you are presently taking mineral oil.

Stop use and ask a doctor if:

  • you have rectal bleeding or no bowel movement after using this product. This could be signs of a serious condition.
  • you need to use laxative for more than 1 week.

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

Uses
  • for temporary relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 12 to 72 hours
Purpose

Stool softener laxative

Directions

Take with glass of water

adults and children 12 years and over:

  • 1 to 3 liquid gels daily. This dose may be taken as single daily dose or in divided doses.

    Children under 12 years of age:

  • 1 liquid gel daily

Children under 2 years of age

Ask a doctor

Other Information
  • store at 15-30 °C (59-86 °F)
  • protect from excessive humidity
  • do not use this product if the safety seal under the cap is torn or missing
Inactive Ingredients

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

Active Ingredient

(in each softgel)

Docusate Sodium 100 mg

Questions Or Comments (Questions or Comments)

Call 1-855-314-1850

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.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC: 076168-069-05 – 25 COUNT


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)