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Diocto by Rugby Laboratories

Dosage form: syrup
Ingredients: Docusate Sodium 60mg in 15mL
Labeler: Rugby Laboratories
NDC Code: 0536-1001

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.

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 over1-6 tablespoons
children 2 to under 12 years1-2½ tablespoons
children under 2 yearsask 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)

DIOCTO 
docusate sodium syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1001
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Docusate Sodium (Docusate) Docusate Sodium60 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
Methylparaben 
menthol 
propylparaben 
water 
Polyethylene Glycols 
Poloxamer 181 
D&C red NO. 33 
FD&C red NO. 40 
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-1001-85473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33406/01/2013
Labeler - Rugby Laboratories (079246066)

Revised: 08/2014
 
Rugby Laboratories

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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