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P LAX DR

Dosage form: tablet, sugar coated
Ingredients: BISACODYL 5mg
Labeler: SPIRIT PHARMACEUTICALS,LLC
NDC Code: 68210-0002

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.

P LAX TABLETS DR, 5 mg-SUGAR COATED: PINK

Drug Facts

Active ingredients (in each tablet)

Bisacodyl 5 mg

Purpose

Stimulant laxative

Uses
  • for relief of occasional constipation(irregularity)
  • this product generally produces bowel movement in 6 to 12 hours

Warnings

Do not use for children under 6 years of age

Ask a doctor before use if you have

  • abdominal pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that persists over a period of 2 weeks

Ask a doctor or pharmacist before use if you are unable to swallow without chewing

When using this product

  • do not chew or crush tablets
  • do not take this product within 1 hour after taking an antacid or milk
  • abdonimal discomfort,faintness, and cramps may occur

Stop use and ask doctor if

  • you need to use more than 1 week
  • rectal bleeding or failure to have a bowel movement occur after use of a laxative.These may be signs of a serious condition

If pregana 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.

Direction
  • each laxative works differently.Adults and children over 12 may need fewer tablets to get the same effect as more tablets of another brand.
  • Start with one tablet and take with water.If one tablet does not produce the desired result,then try two or three tablets daily.
  • Do not take more than three tablets daily
adults and children 12 years of age and older- take 1 to 3 tablets in a single dose once daily
children 6 to under 12 years of age- take 1 tablet once daily
children under 6 years of age- ask a doctor

Other information
  • each tablet contains : calcium 20 mg
  • do not exposee to temperatures above 30°C(85°F)
  • store between 20° to 25°C (68° to 77° F)

Inactive ingredients

lactose,cornstarch,povidone (K-30),sodium startch glycolate,talc,magnesium stearate,methcylic acidcopolymer,polethylene glaycol,sodium hydroxide,sucrose,acacia,gelatin,methylparaben,propylparaben,calcium sulphate dihydrate,titanium dioxide,D&C red#7 lake, FD & C Red #40; D & C Red # 27

PRINCIPAL DISPLAY PANEL - 5 mg Shipping Label

P LAX TABLETS DR, 5 mg-SUGAR COATED: PINK

Each Delayed Release Tablet Contains

(Bisacodyl 5 mg Tablets,USP)

LOT NO :
DRUM NO :
MFG. DATE :

QUANTITY : 10000
NDC NO : 68210-0002-1
EXP. DATE :

WARNING :
KEEP OUT OF THE REACH OF CHILDREN

STORE CONTROLLED ROOM TEMPRATURE 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:

LABELLER CODE : 50654
LIC NO. : 25/5/2009

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"

P LAX DR 
bisacodyl tablet, sugar coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0002
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (BISACODYL) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE 
STARCH, CORN 
POVIDONE K30 
TALC 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOL 
SUCROSE 
ACACIA 
METHYLPARABEN 
FD&C RED NO. 40 
ALUMINUM OXIDE 
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize8mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68210-0002-11 BAG (BAG) in 1 DRUM
110000 TABLET, SUGAR COATED (TABLET) in 1 BAG
2NDC:68210-0002-51 BAG (BAG) in 1 DRUM
250000 TABLET, SUGAR COATED (TABLET) in 1 BAG
3NDC:68210-0002-61 BAG (BAG) in 1 DRUM
365000 TABLET, SUGAR COATED (TABLET) in 1 BAG
4NDC:68210-0002-71 BAG (BAG) in 1 DRUM
470000 TABLET, SUGAR COATED (TABLET) in 1 BAG
5NDC:68210-0002-81 BAG (BAG) in 1 DRUM
580000 TABLET, SUGAR COATED (TABLET) in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/01/2010
Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)
Establishment
NameAddressID/FEIOperations
MISSION VIVACARE LIMITED677604252API MANUFACTURE, RECOVERY

Revised: 04/2010
 
SPIRIT PHARMACEUTICALS,LLC

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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