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

Description

(in each softgel) Docusate Sodium 100 mg

Purpose

Stool softener laxative


Medication Information

Purpose

Stool softener laxative

Description

(in each softgel) Docusate Sodium 100 mg

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

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

Active Ingredient

(in each softgel)

Docusate Sodium 100 mg

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

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

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

Stool softener laxative

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.

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

Active Ingredient

(in each softgel)

Docusate Sodium 100 mg

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

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

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