Docusate Sodium 100mg

Docusate Sodium 100mg
SPL v1
SPL
SPL Set ID 82fab9f8-fdf2-fd32-e053-2a91aa0af596
Route
ORAL
Published
Effective Date 2018-01-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (100 mg)
Inactive Ingredients
D&c Red No. 33 Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycol, Unspecified Sorbitol Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: SCU2 Shape: oval Color: red Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-08-14
Description

Docusate sodium 100 mg

Purpose

Stool softener

Medication Information

Purpose

Stool softener

Description

Docusate sodium 100 mg

Uses
  • relieves occasional constipation (irregularity)

  • generally produces bowel movement in 12 to 72 hours

Warnings


Directions
  • take only by mouth. Doses may be taken as a single daily dose or in divided doses.
adults and children 12 years and over                         take 1-3 softgels daily
children 2 to under 12 years of age take 1 softgel daily
children under 2 years ask a doctor

Do Not Use

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

Questions?

Adverse drug event call: (800) 722-0772 Mon- Fri 8 AM to 5 PM

* This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace®.

Other Information
  • Tamper Evident: do not use if safety seal under cap is broken or missing
  • each capsule contains: sodium 6 mg
  • VERY LOW SODIUM
  • store at 25°C (77°F); excursions permitted between 15 o-30 oC (59 o-86 oF).

Keep tightly closed.

This Package for Households Without Young Children 

Inactive Ingredients

D&C Red #33,Edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, titanium dioxide 

Stop Use and Ask A Doctor If
  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
  • you need to use a stool softener laxative for more than 1 week
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 (1-800-222-1222).

Package Label.principal Display

NDC: 51655-342-20

MFG: 66424-399-10

Docusate Sodium 100 MG

20 Capsules

OTC

Lot#:

Exp. Date:

Each tablet contains 100 mg docusate sodium and 6 mg of sodium

Dosage: See prescriber's instructions

Store between 59-86 degrees F. Protect from light & moisture.

Keep out of the reach of children.

Medication guide is found at www.fda.gov/drugs/drugsafety/ucm085729

Dist. by: SDA Laboratories, Inc Greenwich, CT 06830 Lot#:

Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256

NDC: 51655-342-52

MFG: 66424-399-10

Docusate Sodium 100 MG

30 Capsules

OTC

Lot#:

Exp. Date:

Each tablet contains 100 mg docusate sodium and 6 mg of sodium

Dosage: See prescriber's instructions

Store between 59-86 degrees F. Protect from light & moisture.

Keep out of the reach of children.

Medication guide is found at www.fda.gov/drugs/drugsafety/ucm085729

Dist. by: SDA Laboratories, Inc Greenwich, CT 06830 Lot#:

Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256

NDC: 51655-342-25

MFG: 66424-030-10

Docusate Sodium 100 MG

60 Capsules

OTC

Lot#:

Exp. Date:

Each tablet contains 100 mg docusate sodium and 6 mg of sodium

Dosage: See prescriber's instructions

Store between 59-86 degrees F. Protect from light & moisture.

Keep out of the reach of children.

Medication guide is found at www.fda.gov/drugs/drugsafety/ucm085729

Dist. by: SDA Laboratories, Inc Greenwich, CT 06830 Lot#:

Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256

Active Ingredient (in Each Softgel)

Docusate sodium 100 mg

Ask A Doctor Before Use If You Have
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks

Structured Label Content

Uses
  • relieves occasional constipation (irregularity)

  • generally produces bowel movement in 12 to 72 hours

Purpose

Stool softener

Warnings


Directions
  • take only by mouth. Doses may be taken as a single daily dose or in divided doses.
adults and children 12 years and over                         take 1-3 softgels daily
children 2 to under 12 years of age take 1 softgel daily
children under 2 years ask a doctor

Do Not Use (Do not use)

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

Questions?

Adverse drug event call: (800) 722-0772 Mon- Fri 8 AM to 5 PM

* This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace®.

Other Information (Other information)
  • Tamper Evident: do not use if safety seal under cap is broken or missing
  • each capsule contains: sodium 6 mg
  • VERY LOW SODIUM
  • store at 25°C (77°F); excursions permitted between 15 o-30 oC (59 o-86 oF).

Keep tightly closed.

This Package for Households Without Young Children 

Inactive Ingredients (Inactive ingredients)

D&C Red #33,Edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, titanium dioxide 

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. These could be signs of a serious condition.
  • you need to use a stool softener laxative for more than 1 week
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 (1-800-222-1222).

Package Label.principal Display (Package Label.Principal Display)

NDC: 51655-342-20

MFG: 66424-399-10

Docusate Sodium 100 MG

20 Capsules

OTC

Lot#:

Exp. Date:

Each tablet contains 100 mg docusate sodium and 6 mg of sodium

Dosage: See prescriber's instructions

Store between 59-86 degrees F. Protect from light & moisture.

Keep out of the reach of children.

Medication guide is found at www.fda.gov/drugs/drugsafety/ucm085729

Dist. by: SDA Laboratories, Inc Greenwich, CT 06830 Lot#:

Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256

NDC: 51655-342-52

MFG: 66424-399-10

Docusate Sodium 100 MG

30 Capsules

OTC

Lot#:

Exp. Date:

Each tablet contains 100 mg docusate sodium and 6 mg of sodium

Dosage: See prescriber's instructions

Store between 59-86 degrees F. Protect from light & moisture.

Keep out of the reach of children.

Medication guide is found at www.fda.gov/drugs/drugsafety/ucm085729

Dist. by: SDA Laboratories, Inc Greenwich, CT 06830 Lot#:

Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256

NDC: 51655-342-25

MFG: 66424-030-10

Docusate Sodium 100 MG

60 Capsules

OTC

Lot#:

Exp. Date:

Each tablet contains 100 mg docusate sodium and 6 mg of sodium

Dosage: See prescriber's instructions

Store between 59-86 degrees F. Protect from light & moisture.

Keep out of the reach of children.

Medication guide is found at www.fda.gov/drugs/drugsafety/ucm085729

Dist. by: SDA Laboratories, Inc Greenwich, CT 06830 Lot#:

Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256

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

Docusate sodium 100 mg

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:47.104621 · Updated: 2026-03-14T22:55:29.885496