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Docusate Sodium Liquid by Rij Pharmaceutical Corporation

Medically reviewed on April 3, 2018

Dosage form: liquid
Ingredients: Docusate sodium 10mg in 1mL
Labeler: Rij Pharmaceutical Corporation
NDC Code: 53807-216

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 (per teaspoonful = 5 mL)

Docusate Sodium 50 mg

Purpose

Stool Softener

Uses
  • prevents / relieves dry hard stool
  • results usually occur 1 to 3 days after the first dose

Warnings Do not use
  • when abdominal pain, nausea, or vomiting are present
  • for more than one week unless directed by a doctor
Ask a doctor before use if you
  • are taking mineral oil
  • have noticed a sudden change in bowel habits that lasts more than 2 weeks
Stop use and ask a doctor if
  • you have no bowel movement within 3 days
  • you have rectal bleeding
  • these could be signs of a serious condition
  • a skin rash occurs
  • you experience throat irritation

If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children. In case of accidental overdose, seek professional assisstance or contact a Poison Control Center immediately.

Directions
  • follow dosing directions below or take as directed by doctor
  • must be given in a 6 to 8 oz glass of milk or fruit juice to prevent throat irritation
  • may be taken as a single daily dose or in divided doses
  • take maximum dose daily until first bowel movement, dosage should then be reduced according to individual response
  • do not exceed recommended dose
  • shake well before using
Adults and children 12 years and over
1 to 4 teaspoons (50 to 200 mg)
Children under 12 years of age
ask a doctor

1 teaspoon = 5 mL


TAMPER EVIDENT: Do not use if breakaway band on cap is broken or missing.


Other information
  • Store at room temperature 15°-30°C (59°-86°F)
  • protect from excessive heat
  • Keep tightly closed
  • Dispense in tight, light resistant container as defined in the USP
  • each teaspoon (5 mL) contains: sodium 15 mg

Inactive ingredients

citric acid, D&C Red #33, flavor, parabens, poloxamer, propylene glycol, sodium citrate, sorbitol, sucrose, and water.

DOCUSATE SODIUM LIQUID 
docusate sodium liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53807-216
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Docusate sodium (Docusate) Docusate sodium10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
D&C red no. 33 
methylparaben 
propylparaben 
propylene glycol 
sodium citrate 
water 
Poloxamer 407 
SUCROSE 
SORBITOL 
Product Characteristics
ColorPINKScore    
ShapeSize
Flavor RASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:53807-216-08236 mL in 1 BOTTLE, PLASTIC
2NDC:53807-216-16473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/16/1999
Labeler - Rij Pharmaceutical Corporation (144679156)

 
Rij Pharmaceutical Corporation

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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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