P LAX DR: Package Insert and Label Information

P LAX DR- bisacodyl tablet, sugar coated
SPIRIT PHARMACEUTICALS,LLC

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 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”

PRINCIPAL DISPLAY PANEL -- 5mg Shipping Label
(click image for full-size original)
P LAX DR
bisacodyl tablet, sugar coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-0002
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BISACODYL (BISACODYL) BISACODYL 5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE
STARCH, CORN
POVIDONE K30
TALC
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL
SUCROSE
ACACIA
METHYLPARABEN
FD&C RED NO. 40
ALUMINUM OXIDE
Product Characteristics
Color PINK Score no score
Shape ROUND Size 8mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68210-0002-1 1 BAG (BAG) in 1 DRUM contains a BAG
1 10000 TABLET, SUGAR COATED (TABLET) in 1 BAG This package is contained within the DRUM (68210-0002-1)
2 NDC:68210-0002-5 1 BAG (BAG) in 1 DRUM contains a BAG
2 50000 TABLET, SUGAR COATED (TABLET) in 1 BAG This package is contained within the DRUM (68210-0002-5)
3 NDC:68210-0002-6 1 BAG (BAG) in 1 DRUM contains a BAG
3 65000 TABLET, SUGAR COATED (TABLET) in 1 BAG This package is contained within the DRUM (68210-0002-6)
4 NDC:68210-0002-7 1 BAG (BAG) in 1 DRUM contains a BAG
4 70000 TABLET, SUGAR COATED (TABLET) in 1 BAG This package is contained within the DRUM (68210-0002-7)
5 NDC:68210-0002-8 1 BAG (BAG) in 1 DRUM contains a BAG
5 80000 TABLET, SUGAR COATED (TABLET) in 1 BAG This package is contained within the DRUM (68210-0002-8)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 05/01/2010
Labeler — SPIRIT PHARMACEUTICALS,LLC (179621011)
Establishment
Name Address ID/FEI Operations
MISSION VIVACARE LIMITED 677604252 API MANUFACTURE, RECOVERY

Revised: 04/2010 SPIRIT PHARMACEUTICALS,LLC

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