DOCUSATE SODIUM capsule, liquid filled

Docusate Sodium by

Drug Labeling and Warnings

Docusate Sodium by is a Otc medication manufactured, distributed, or labeled by Marlex Pharmaceuticals Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

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Docusate Sodium 100 mg

Drug Facts

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener laxative

Uses

• relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours

Warnings

Do not use

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

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.

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.

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

Other informaiton

• each softgel contains: sodium 7 mg
  
• store at room temperature 15º-25ºC (59º-77ºF) and avoid excessive heat

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

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10135-111
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	RED	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	SCU1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10135-111-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	04/01/2017

Labeler - Marlex Pharmaceuticals Inc (782540215)