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Stool Softener Liquid

Medically reviewed on September 12, 2017

Dosage form: liquid
Ingredients: DOCUSATE SODIUM 50mg in 5mL
Labeler: AMERISOURCEBERGEN DRUG CORPORATION
NDC Code: 46122-399

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.

GNP DOCUSATE LIQUID

Active ingredient (in each 5 mL teaspoonful)

Docusate Sodium 50 mg

Purpose

Stool Softener Laxative

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours

Warnings

Do not use for more than one week unless directed by a doctor

Ask a doctor before use if you

  • have abdominal pain, nausea, or vomiting
  • are taking mineral oil
  • have noticed a sudden change in bowel habits that lasts more than 14 days

Stop use and ask a doctor if

  • you have rectal bleeding or failure to have a bowel movement within 3 days. 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 overdose, get medical help or contact a poison control Center right away.

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 daily dose until first bowel movement, then reduce dose according to individual response
  • shake well before using

Adults and children 12 years and over
1 to 4 teaspoonfuls (5 to 20 mL)
Children under 12 years of age
ask a doctor

Other information
  • Each teaspoonful contains: sodium 15 mg
  • Store at room temperature 15°- 30° C (59°-86° F)
  • protect from excessive heat
  • Keep tightly closed

Inactive ingredients

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

package label

NDC 46122-399-43

Compare to Colace® Liquid active ingredient *

GOOD NEIGHBOR PHARMACY

STOOL
SOFTENER
LIQUID
Docusate Sodium
Relieves Constipation
50 mg/5 mL
16 FL OZ (473 mL)

STOOL SOFTENER LIQUID 
docusate sodium liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-399
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
ANHYDROUS CITRIC ACID 
D&C RED NO. 33 
METHYLPARABEN 
PROPYLPARABEN 
POLYETHYLENE GLYCOLS 
SODIUM CITRATE 
WATER 
POLOXAMER 407 
SUCROSE 
SORBITOL 
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:46122-399-43473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33409/01/2017
Labeler - AMERISOURCEBERGEN DRUG CORPORATION (007914906)
Registrant - GERI-CARE PHARMACEUTICAL CORP (611196254)

 
AMERISOURCEBERGEN DRUG CORPORATION

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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