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Stool Softener DC Laxative

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE CALCIUM 240mg
Labeler: Rugby Laboratories Inc
NDC Code: 0536-3755

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 Calcium 240 mg

Purpose

Stool softener

Uses

for relief of occasional constipation. This product 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
  • for longer than 1 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
  • you fail to have a bowel movement after use

These could be signs of s 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
  • adults and children over 12 years of age: take 1 softgel daily for several days, or until bowel movements are normal, or as directed by a doctor
  • children under 12 years of age: take as directed by a doctor

Other information
  • store between 15º-30ºC (59º-86ºF)

Inactive ingredients

corn oil, D&C red #33, edible white ink, FD&C red #40, gelatin, glycerin, purified water and sorbitol special.

Questions or comments?

1-800-645-2158

Principal Display Panel

Compare to active ingredient in SURFAK®*

Safe, Effective, Non-Habit Forming

Stool Softener Laxative DC

Docusate Calcium USP, 240 mg

SOFTGEL CAPSULES

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

*Rugby Laboratories is not affiliated with the owner of the trademark Surfak®.

Distributed by: Rugby Laboratories

31778 Enterprise Drive

Livonia, MI  48150

www.rugbylaboratories.com

Product Labeling

Rugby Stool Softener Laxative DC Softgel

 

STOOL SOFTENER DC LAXATIVE 
docusate calcium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-3755
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE CALCIUM (DOCUSATE) DOCUSATE CALCIUM240 mg
Inactive Ingredients
Ingredient NameStrength
CORN OIL 
D&C RED NO. 33 
FD&C RED NO. 40 
GELATIN 
GLYCERIN 
WATER 
SORBITOL 
Product Characteristics
ColorRED (RED) Scoreno score
ShapeOVAL (OVAL) Size8mm
FlavorImprint CodeP58
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-3755-011 BOTTLE (1 BOTTLE) in 1 BOX
1100 CAPSULE, LIQUID FILLED (100 CAPSULE) in 1 BOTTLE
2NDC:0536-3755-05500 CAPSULE, LIQUID FILLED (500 CAPSULE) in 1 BOTTLE
3NDC:0536-3755-101000 CAPSULE, LIQUID FILLED (1000 CAPSULE) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33412/01/2011
Labeler - Rugby Laboratories Inc (191427277)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 04/2013
 
Rugby Laboratories Inc

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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