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Docusate Sodium by Physicians Total Care, Inc.

Medically reviewed on January 3, 2018

Dosage form: liquid
Ingredients: DOCUSATE SODIUM 50mg in 5mL
Labeler: Physicians Total Care, Inc.
NDC Code: 54868-6209

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.

Drug Facts

Active ingredient (in each teaspoon)

Docusate Sodium 50 mg

Purpose

Stool Softener Laxative

Uses
  • 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
  • may be taken once daily or in divided doses
  • give dose in 1/2 glass of milk, fruit juice or infant formula to mask bitter taste and prevent throat irritation
  • adults and children over 121 to 7 teaspoons
    children 2 to under 121 to 3 teaspoons
    children under 2ask a doctor

Other information
  • each teaspoon contains: sodium 5 mg
  • shake well before using
  • store at controlled room temperature 15° - 30°C (59° - 86°F)
  • dispense contents with a child resistant closure in a tight, light resistant container as defined in the USP.

Inactive ingredients

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

 

Questions or comments?
  • Call 1-800-262-9010

    Mon. - Thurs. 9:00 am - 4:30 pm EST,

    Fri. 9:00 am - 2:30 pm EST.

    Serious side effects associated with use of this product may be reported to this number.

 

REV. 771:04 07/10

PRINCIPAL DISPLAY PANEL

DOCU LIQUID

(Docusate Sodium 50 mg/5 mL)

NDC 54868-6209-0

NET CONTENTS ONE PINT (473 mL)

STOOL SOFTENER LAXATIVE

 
TAMPER EVIDENT: FOR YOUR PROTECTION, THIS BOTTLE HAS A SAFETY SEAL AROUND THE NECK OR UNDER THE CAP.

 

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

 


Additional bar code labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma        74146

DOCUSATE SODIUM 
docusate sodium liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-6209(NDC:50383-771)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM50 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33 
METHYLPARABEN 
POLYETHYLENE GLYCOL 4000 
PROPYLENE GLYCOL 
PROPYLPARABEN 
SODIUM BENZOATE 
SODIUM CITRATE 
VANILLA 
WATER 
POLOXAMER 181 
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:54868-6209-0473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33412/07/2010
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIOperations
Physicians Total Care, Inc.194123980relabel

 
Physicians Total Care, Inc.

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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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