DIOCTO- docusate sodium syrup
Rugby Laboratories

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 15 mL tablespoonful)

Docusate Sodium 60 mg

Purpose

Stool Softener Laxative

Use

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

Warnings

Do not use

•: if you are presently 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

adults and children 12 years and over	1-6 tablespoons
children 2 to under 12 years	1-2½ tablespoons
children under 2 years	ask a doctor

Other information

•: each tablespoonful contains: sodium 4 mg
•: store at room temperature
•: protect from freezing

Inactive ingredients

D&C red #33, FD&C red #40, menthol, methylparaben, peppermint oil, poloxamer 181, polyethylene glycol, propylparaben, purified water, sodium benzoate, sodium citrate, sucrose. Citric Acid or Sodium Hydroxide may be used to adjust pH

Questions or comments?

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 0536-1001-85

Diocto
Syrup

Docusate Sodium
60 mg/15 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 syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0536-1001
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Docusate Sodium (UNII: F05Q2T2JA0) (Docusate - UNII:M7P27195AG)	Docusate Sodium	60 mg in 15 mL

Ingredient Name	Strength
Inactive Ingredients
Methylparaben (UNII: A2I8C7HI9T)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
Poloxamer 181 (UNII: 09Y8E6164A)
D&C red NO. 33 (UNII: 9DBA0SBB0L)
FD&C red NO. 40 (UNII: WZB9127XOA)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0536-1001-85	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2013	09/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	06/01/2013	09/30/2020

Labeler - Rugby Laboratories (079246066)

Revised: 9/2019

Document Id: 221543f2-c1d5-41ae-b687-c490c7fc89bd

Set id: 764a0354-262b-4317-80d1-189fcddafbc0

Version: 2

Effective Time: 20190905

Rugby Laboratories