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Docusate Sodium by Reliable 1 Laboratories LLC

Dosage form: capsule
Ingredients: DOCUSATE SODIUM 100mg
Labeler: Reliable 1 Laboratories LLC
NDC Code: 69618-043

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 100 mg

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 directed 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

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop use and ask a doctor if

  • you have rectal bleeding or fail to have bowel movement after use of a laxative. These could be sings of a serious condition.
  • you need to use a stool softener 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
adults and children 12 years and overtake 1 -3 softgels once daily or in divided doses
children 2 to under 12 years of age1 softgel once daily
children under 2 yearsask a doctor

  • each softgel contains: sodium 5 mg
  • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Inactive ingredients

citric acid, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special and white edible ink

Questions or comments ?

Call 516-341-066 8:30 am - 4:30 pm ET, Monday - Friday

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

*Reliable-1 Laboratories LLC is not affiliated with the owner of the trademark Colace®

Distributed by: Reliable-1 Laboratories LLC Valley Stream, NY 11580 www.reliable1labs.com

NDC 69618-043-10

Docusate Sodium 100 mg

STOOL SOFTENER

LAXATIVE

1000 SOFTGELS

DOCUSATE SODIUM 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-043
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 
ANHYDROUS CITRIC ACID 
FD&C RED NO. 40 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 6 
WATER 
SORBITOL 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
Product Characteristics
ColorredScoreno score
ShapeOVALSize13mm
FlavorImprint CodePC1
Contains    
Packaging
#Item CodePackage Description
1NDC:69618-043-01100 CAPSULE in 1 BOTTLE, PLASTIC
2NDC:69618-043-101000 CAPSULE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33404/01/2016
Labeler - Reliable 1 Laboratories LLC (079718111)

Revised: 04/2016
 
Reliable 1 Laboratories LLC

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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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