Diocto by Rugby Laboratories, Inc. / Hi-Tech Pharmacal Co., Inc. Drug Facts

Drug Details [pdf]

DIOCTO- docusate sodium syrup
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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Drug Facts

Active ingredient (in each 15mL 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 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	1-6 tablespoons
children 2 to under 12 years	1-2½ tablespoons
children under 2 years	ask a doctor

Other information

each tablespoon 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, polaxamer 181, polyethylene glycol, propylparaben, purified water, sodium benzoate, sodium citrate, sucrose

Citric acid may be used to adjust pH.

Questions or comments?

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

Rev. 770:03 10/08

Package/Label Principal Display Panel

COMPARE TO ACTIVE INGREDIENT IN COLACE® *

Rugby®

NDC: 0536-0600-85

Diocto Syrup

Docusate Sodium 60 mg/15 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 syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-0600
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
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEPPERMINT OIL (UNII: AV092KU4JH)
POLOXAMER 181 (UNII: 09Y8E6164A)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SUCROSE (UNII: C151H8M554)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 0536-0600-85	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/1999	07/29/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	10/01/1999	07/29/2018

Labeler - Rugby Laboratories, Inc. (079246066)

Revised: 12/2019

Document Id: 91c3378e-39ad-4442-ad3f-4a20a2e25200

Set id: afac6c3d-a513-4655-9545-3e489f26558a

Version: 2

Effective Time: 20191218