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Docusate Sodium by American Health Packaging

Medically reviewed on September 7, 2017

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 100mg
Labeler: American Health Packaging
NDC Code: 60687-129

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.

DOCUSATE SODIUM, USP

Stool Softener Laxative

Drug Facts

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener laxative

Uses
  • for relief of occasional constipation (irregularity)
  • generally produces a bowel movement within 12 to 72 hours

Warnings

Do not use

  • if you are currently taking mineral oil, unless directed by a doctor
  • when abdominal pain, nausea or vomiting are present unless directed by a doctor
  • for longer than one week unless directed by a doctor

Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of 2 weeks.

Stop use and ask a doctor if you have rectal bleeding or you fail to have a bowel movement after use of a laxative. This may indicate a serious condition.

If pregnant or breast-feeding, ask a health care 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 of age and over

take 1 to 3 softgels daily

children 2 to under 12 years of age

take 1 softgel daily

children under 2 years of age

ask a doctor

Other information
  • Each softgel contains: sodium 7 mg VERY LOW SODIUM
  • Store at room temperature between 15° to 30°C (59° to 86°F)
  • FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Inactive ingredients

FD&C Red #40, FD&C Yellow #6, Gelatin USP, Glycerin USP, Polyethylene Glycol 400 NF, Purified Water USP, Sorbital USP

The drug product contained in this package is from NDC # 61301-8001, SWISSCAPS Romania srl.

Distributed by:
American Health Packaging
2550 John Glenn Avenue, Suite A
Columbus, OH 43217

712901
0412901/0216PS

Principal Display Panel – Carton – 100 mg

NDC 60687-129-01

DOCUSATE SODIUM, USP
Stool Softener Laxative

100 mg

100 Softgels (10 x 10)

The drug product contained in this package is from NDC # 61301-8001,
SWISSCAPS Romania srl.

Distributed by:
American Health Packaging
2550 John Glenn Avenue, Suite A
Columbus, OH 43217

712901
0412901/0216PS

Principal Display Panel - Blister – 100 mg

DOCUSATE SODIUM, USP
Stool Softener Laxative
Softgel

100 mg

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60687-129
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN, UNSPECIFIED 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
WATER 
SORBITOL 
Product Characteristics
Colorred (Reddish) Scoreno score
ShapeOVALSize12mm
FlavorImprint CodeSCU1
Contains    
Packaging
#Item CodePackage Description
1NDC:60687-129-01100 BLISTER PACK in 1 BOX, UNIT-DOSE
1NDC:60687-129-111 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33411/01/2015
Labeler - American Health Packaging (929561009)
Registrant - Swiss Caps Romania (565466997)
Establishment
NameAddressID/FEIOperations
Swiss Caps Romania565466997manufacture(60687-129)
Establishment
NameAddressID/FEIOperations
American Health Packaging929561009repack(60687-129)

 
American Health Packaging

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Further information

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

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