DIOCTO- docusate sodium liquid
The Harvard Drug Group, LLC

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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Diocto

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Docusate Sodium 50 mg

Purpose

Stool Softener Laxative

Use

•: relieves occasional constipation
•: generally produces bowel movement in 12-72 hours

Warnings

Do not use

•: if you are taking mineral oil
•: when adominal pain, nausea, or vomiting are present
•: for longer than one week

Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts over two 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
•: you fail to have a bowel movement after use of this product

These may indicate 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

•: take once daily or in divided doses
•: mix with milk or fruit juice to prevent throat irritation

adults and children 12 years and over	1-7 teaspoons
children 2 to under 12 years	1-3 teaspoons
children under 2 years	ask a doctor

Other information

•: each teaspoonful contains: sodium 5 mg
•: store at room temperature
•: protect from freezing

Inactive ingredients

D&C red #33, FD&C red #40, methylparaben, poloxamer 181, polyethylene glycol, propylene glycol, propylparaben, purified water, vanilla flavoring. Sodium citrate may be used to adjust pH.

Questions or comments?

Call 1-800-645-2158

Dist. by: Rugby Laboratories
31778 Enterprise Drive
Livonia, MI 48150

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

COMPARE TO
ACTIVE INGREDIENT IN
COLACE®*

Rugby®

NDC 0536-0590-85

NEW
FORMULA

Diocto
Liquid

Docusate Sodium
50 mg/5 mL

STOOL SOFTENER
LAXATIVE

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

One Pint (473 mL)

Principal Display Panel - 473 mL Bottle Label

DIOCTO
docusate sodium liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0536-0590
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Docusate Sodium (UNII: F05Q2T2JA0) (Docusate - UNII:M7P27195AG)	Docusate Sodium	50 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
Methylparaben (UNII: A2I8C7HI9T)
propylene glycol (UNII: 6DC9Q167V3)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
FD&C Red No. 40 (UNII: WZB9127XOA)
D&C Red No. 33 (UNII: 9DBA0SBB0L)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
Poloxamer 181 (UNII: 09Y8E6164A)

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor	VANILLA	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0536-0590-85	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2013	09/30/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	03/01/2013	09/30/2019

Labeler - The Harvard Drug Group, LLC (079246066)

Registrant - The Harvard Drug Group, LLC (079246066)

Name	Address	ID/FEI	Business Operations
Establishment
The Harvard Drug Group, LLC		079246066	REPACK(0536-0590)

Revised: 11/2017

Document Id: 6278090d-1a6a-4085-bc4a-a2e2ed3a2662

Set id: 095a300f-5cc2-41f9-86c4-670a27c5ec32

Version: 3

Effective Time: 20171117

The Harvard Drug Group, LLC