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DOCUSATE SODIUM by SPIRIT PHARMACEUTICALS,LLC

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 50mg
Labeler: SPIRIT PHARMACEUTICALS,LLC
NDC Code: 68210-0402

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 CAPSULES USP 50 MG

Drug Facts

Active ingredient
(in each capsule)

Docusate sodium 50 mg

Purpose

Stool softener

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 overtake 1-6 capsules daily
children 2 to under 12 years of agetake 1-3 capsules daily
children under 2 yearsask a doctor

Inactive ingredients

D&C Red No. 33, FD&C Red No. 40, gelatin, glycerin, PEG 400, propylene glycol, sorbitol

Questions? 1-888-726-7535
(8am-5pm, EST, Mon.-Fri.).

PRINCIPAL DISPLAY PANEL

Docusate Sodium capsules USP 50mg
Each Softgel Contains:
(Docusate Sodium USP 50mg)

LOT NO :

DRUM NO :

MFG DATE :

QUANTITY :

NDC NO : 68210-0402-

EXP DATE :

WARNING:
KEEP OUT OF REACH OF CHILDREN

STORE CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING

THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH
THE F.D & C. ACT AND REGULATIONS THEREUNDER.

MANUFACTURED BY:
SOFTGEL HEALTHCARE PVT LIMITED
INDIA
LABELLER CODE : 35916
LIC NO. : TN/DRUGS/00002124

MANUFACTURED FOR:
SPIRIT PHARMACEUTICALS LLC
225 LINCOLN HWY, STE 205
FAIRLESS HILLS, PA 19030
PH.# 215 943 4000
FAX.# 215 943 4039

CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"

  • 1 – 10
  • 2 – 30
  • 3 – 100
  • 4 – 1000
  • 5 – 16000

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0402
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM50 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 
GLYCERIN 
GELATIN 
SORBITOL 
WATER 
PROPYLENE GLYCOL 
D&C RED NO. 33 
Product Characteristics
ColorREDScoreno score
ShapeOVALSize10mm
FlavorImprint CodeDO4
Contains    
Packaging
#Item CodePackage Description
1NDC:68210-0402-11 BAG (BAG) in 1 BOX
110 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BAG
2NDC:68210-0402-21 BAG (BAG) in 1 BOX
230 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BAG
3NDC:68210-0402-31 BAG (BAG) in 1 BOX
3100 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BAG
4NDC:68210-0402-41 BAG (BAG) in 1 BOX
41000 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BAG
5NDC:68210-0402-51 BAG (BAG) in 1 BOX
516000 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart310.54510/01/2009
Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)
Establishment
NameAddressID/FEIOperations
SOFTGEL HEALTHCARE PVT LTD675584180MANUFACTURE

Revised: 11/2009
 
SPIRIT PHARMACEUTICALS,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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