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Diocto

Rugby Laboratories, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Diocto 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

Diocto

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 label Item Code (Source) NDC:0536-0600
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM DOCUSATE 60 mg

Inactive Ingredients

Ingredient Name Strength
D&C RED NO. 33
FD&C RED NO. 40
MENTHOL
METHYLPARABEN
PEPPERMINT OIL
POLOXAMER 181
polyethylene glycol 400
PROPYLPARABEN
water
SODIUM BENZOATE
TRISODIUM CITRATE DIHYDRATE
SUCROSE
ANHYDROUS CITRIC ACID

Product Characteristics

Color
PINK

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0536-0600-85 473 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 1999-10-01


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Be sure to consult your doctor before taking any medication!
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