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Diocto

The Harvard Drug Group, LLC

Diocto


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Diocto 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)

Diocto

Diocto

Docusate Sodium LIQUID

Product Information

Product Type Human otc drug label 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 50 mg

Inactive Ingredients

Ingredient Name Strength
METHYLPARABEN
propylene glycol
PROPYLPARABEN
water
POLYETHYLENE GLYCOLS
FD&C RED NO. 40
D&C RED NO. 33
SODIUM CITRATE
POLOXAMER 181

Product Characteristics

Color
PINK

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0536-0590-85 473 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2013-03-01


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Be sure to consult your doctor before taking any medication!
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