OTC Medication Information: DOCUSATE SODIUM

DOCUSATE SODIUM- docusate sodium capsule, liquid filled
Dolgencorp, 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.

Drug Facts

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool Softner

Uses

  • relieves occasional constipation (irregularity)
  • this product generally produces a bowel movement within 12 to 72 hours

Warnings

Do not use

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

Ask a doctor before use if you have

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

Stop use and ask a doctor if

  • you have rectal bleeding ot no bowel movement after use of a laxative. These could be signs of a serious condition.
  • yo 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

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 of age: ask a doctor

Other information

  • Store at 25°C (77°F), excursions permitted between 15°-30°C (59°-86°F)
  • Keep tightly closed.

Inactive ingredients

gelatin, glycerin, polyethylene glycol-400, povidone, propylene glycol, purified water, sorbitol solution, titanium dioxide.

Questions or comments?

1-888-309-9030

PRINCIPAL DISPLAY PANEL

DGTM Health

Compare to the active ingredient of Colace®*

STOOL SOFTENER CLEAR

DOCUSATE SODIUM 100 mg

Relieves constipation

Gentle Relief

Stimulant-Free
Dye-Free

100 Softgels

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

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DOCUSATE SODIUM
docusate sodium capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-223
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 100 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL 400
POVIDONE K30
PROPYLENE GLYCOL
WATER
SORBITOL
TITANIUM DIOXIDE
Product Characteristics
Color white (Transparent Softgels appear slightly Yellow) Score no score
Shape OVAL Size 12mm
Flavor Imprint Code S50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55910-223-10 1 BOTTLE in 1 CARTON contains a BOTTLE
1 100 CAPSULE, LIQUID FILLED in 1 BOTTLE This package is contained within the CARTON (55910-223-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 05/21/2019
Labeler — Dolgencorp, Inc. (068331990)

Revised: 11/2022 Dolgencorp, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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