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Stool Softener Syrup

Dosage form: syrup
Ingredients: DOCUSATE SODIUM 60mg in 15mL
Labeler: AMERISOURCEBERGEN DRUG CORPORATION
NDC Code: 46122-400

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 SYRUP

Active ingredient (in each 15 mL tablespoonful)

Docusate Sodium 60 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
  • have a sodium-restricted diet

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 over1 to 3 tablespoonfuls (15 to 45 mL)
Children under 12 years of ageask a doctor

Other information
  • Each 15 mL tablespoonful contains: sodium 51 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, FD&C Red #40, flavors, glycerin, propylene glycol, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, water.

package label

NDC 46122-400-43

Compare to Colace® Syrup active ingredient *

GOOD NEIGHBOR PHARMACY

STOOL
SOFTENER
SYRUP
Docusate Sodium
Relieves Constipation
60 mg/15 mL
16 FL OZ (473 mL)

STOOL SOFTENER SYRUP 
docusate sodium syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-400
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
ANHYDROUS CITRIC ACID 
D&C RED NO. 33 
SODIUM CITRATE, UNSPECIFIED FORM 
SACCHARIN SODIUM (SACCHARIN)  
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SORBITOL 
FD&C RED NO. 40 
GLYCERIN 
Product Characteristics
ColorredScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:46122-400-43473 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)

Revised: 10/2017
 
AMERISOURCEBERGEN DRUG CORPORATION

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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