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Stool Softener by AmerisourceBergen (Good Neighbor Pharmacy) 46122

Medically reviewed on February 6, 2018

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 100mg
Labeler: AmerisourceBergen (Good Neighbor Pharmacy) 46122
NDC Code: 46122-451

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 softgel)

Docusate sodium 100 mg

Purpose

Stool softener laxative

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

Warnings

Do not use

if you are presently taking mineral oil, unless told to do so by a doctor.

Ask a doctor before use if you have
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if
  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
  • you need to use a laxative for more than 1 week

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 only by mouth. Doses may be taken as a single daily dose or in divided doses.
 adults and children 12 years and over  take 1-3 softgels daily
 children 2 to under 12 years of age take 1 softgel daily
 children under 2 years ask a doctor

Other information
  • each softgel contains: sodium 6 mg
  • store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

D&C red #33,edible ink, FD&C blue#1*, FD&C red#40, FD&C yellow#6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water, sorbitan, sorbitol, titanium dioxide

*contains one or more of these ingredients

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

†Compare to Colace® Regular Strength Stool Softener active ingredient

Stool Softener

Docusate Sodium 100 mg

stool softener laxative

SOFTGELS

†This product is not manufactured or distributed by Purdue Products L.P., distributor of Colace® Regular strength Stool Softener.

Distributed by AmerisourceBergen

1300 Morris drive, Chesterbrook, PA 19087

Questions or Concerns? Visit us at www.mygnp.com

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Product Labeling

GOOD NEIGHBOR PHARMACY Stool Softener

STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-451
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOL, UNSPECIFIED 
PROPYLENE GLYCOL 
WATER 
SORBITAN 
SORBITOL 
TITANIUM DIOXIDE 
Product Characteristics
ColorRED, WHITEScoreno score
ShapeOVALSize12mm
FlavorImprint CodeP10;SCU2;D1
Contains    
Packaging
#Item CodePackage Description
1NDC:46122-451-721 BOTTLE, PLASTIC in 1 BOX
160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
2NDC:46122-451-78100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
3NDC:46122-451-85250 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33410/01/2017
Labeler - AmerisourceBergen (Good Neighbor Pharmacy) 46122 (007914906)

 
AmerisourceBergen (Good Neighbor Pharmacy) 46122

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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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