Docusate Sodium

Docusate Sodium
SPL v4
SPL
SPL Set ID c34e6f3d-9a11-4164-a26c-1ef62513c184
Route
ORAL
Published
Effective Date 2019-10-18
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 Glycerin Polyethylene Glycol 400 Water Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: SCU1 Shape: oval Color: red Size: 13 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-04-01
Description

DOCUSATE SODIUM- docusate sodium capsule Marlex Pharmaceuticals, Inc. Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------- Docusate Sodium 100 mg Drug Facts

Purpose

Stool softener laxative

Medication Information

Purpose

Stool softener laxative

Description

DOCUSATE SODIUM- docusate sodium capsule Marlex Pharmaceuticals, Inc. Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------- Docusate Sodium 100 mg Drug Facts

Uses
  • relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours
Other
  • each softgel contains: s odium 7 mg

  • store at room temperature 15º-25ºC (59º-77ºF) and avoid excessive heat
Section 42229-5

DOCUSATE SODIUM- docusate sodium capsule Marlex Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Docusate Sodium 100 mg

Drug Facts

Directions
adults and children 12 years and over take 1 - 3 softgels once daily or in divded doses
children 2 to under 12 years of age 1 softgel once daily
children under 2 years ask a doctor
Do Not Use

if you are presently taking mineral oil, unless directed to do so by a doctor

Inactive Ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol 400 NF, purified water, sorbitol

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

*Marlex Pharmaceuticals, Inc., is not affiliated with the owner of the trademark Colace®

Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Made in Romania

Principal Display Panel

NDC 10135-0111-01

Docusate Sodium

100 mg

100 Softgels

Active Ingredient (in Each

Docusate sodium 100 mg

Stop Use and Ask A Doctor If
  • you have rectal bleeding or fail to have a bowel movement after use of a laxative.

  • you need to use stool softner laxative for more than 1 week

These could be sings of a serious condition.

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.

Ask A Doctor Before Use If You Have
  • stomach pain

  • Nausea

  • vomiting

  • noticed a sudden change in bowel habits that lasts over 2 weeks
Ask A Doctor Or Pharmacist Before Use If You Are

taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Structured Label Content

Uses
  • relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours
Other
  • each softgel contains: s odium 7 mg

  • store at room temperature 15º-25ºC (59º-77ºF) and avoid excessive heat
Section 42229-5 (42229-5)

DOCUSATE SODIUM- docusate sodium capsule Marlex Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Docusate Sodium 100 mg

Drug Facts

Purpose

Stool softener laxative

Directions
adults and children 12 years and over take 1 - 3 softgels once daily or in divded doses
children 2 to under 12 years of age 1 softgel once daily
children under 2 years ask a doctor
Do Not Use (Do not use)

if you are presently taking mineral oil, unless directed to do so by a doctor

Inactive Ingredients (Inactive ingredients)

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol 400 NF, purified water, sorbitol

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

*Marlex Pharmaceuticals, Inc., is not affiliated with the owner of the trademark Colace®

Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Made in Romania

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 10135-0111-01

Docusate Sodium

100 mg

100 Softgels

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

Docusate sodium 100 mg

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you have rectal bleeding or fail to have a bowel movement after use of a laxative.

  • you need to use stool softner laxative for more than 1 week

These could be sings of a serious condition.

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.

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

  • Nausea

  • vomiting

  • noticed a sudden change in bowel habits that lasts over 2 weeks
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:46.964443 · Updated: 2026-03-14T22:59:52.177031