DIOCTO- docusate sodium liquid
Rugby Laboratories, 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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Active ingredient (in each 5 mL teaspoon)

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 presently taking mineral oil
when abdominal 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	1-7 teaspoons
children 2 to under 12 years	1-3 teaspoons
children under 2 years	ask a doctor

Other information

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

Inactive ingredients

D&C Red #33, methylparaben, planifoline, poloxamer 181, polyethylene glycol, propylene glycol, propylparaben, purified water. Sodium citrate may be used to adjust pH.

Questions or comments?

call 1-800-645-2158 9 am - 5 pm ET, Monday - Friday

Rev. 771:03 09/08

Package/Label Principal Display Panel

COMPARE TO ACTIVE INGREDIENT IN COLACE®*

Rugby®

NDC 0536-0590-85

Diocto Liquid

Docusate Sodium 50 mg/5 mL

STOOL SOFTENER

LAXATIVE

TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING

One Pint (473 mL)

Rugby

SATISFACTION GUARANTEED OR YOUR MONEY BACK

DIOCTO
docusate sodium liquid

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (DOCUSATE)	DOCUSATE SODIUM	50 mg in 5 mL

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 33
METHYLPARABEN
POLOXAMER 181
POLYETHYLENE GLYCOL 400
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
TRISODIUM CITRATE DIHYDRATE
SODIUM BENZOATE

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor	VANILLA (natural & artificial vanilla flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:0536-0590-85	473 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	07/01/1999

Labeler - Rugby Laboratories, Inc. (109178264)

Establishment
Name	Address	ID/FEI	Business Operations
Hi-Tech Pharmacal Co., Inc.		101196749	MANUFACTURE(0536-0590)

Revised: 09/2011

Document Id: 095a300f-5cc2-41f9-86c4-670a27c5ec32

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

Version: 1

Effective Time: 20110920

Rugby Laboratories, Inc.