P LAX DR- bisacodyl tablet, sugar coated

SPL UNCLASSIFIED SECTION

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"

INGREDIENTS AND APPEARANCE

P LAX DR
bisacodyl tablet, sugar coated

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BISACODYL (UNII: 10X0709Y6I) (BISACODYL - UNII:10X0709Y6I)	BISACODYL	5 mg

Ingredient Name	Strength
Inactive Ingredients
LACTOSE (UNII: J2B2A4N98G)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE K30 (UNII: U725QWY32X)
TALC (UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
SUCROSE (UNII: C151H8M554)
ACACIA (UNII: 5C5403N26O)
METHYLPARABEN (UNII: A2I8C7HI9T)
FD&C RED NO. 40 (UNII: WZB9127XOA)
ALUMINUM OXIDE (UNII: LMI26O6933)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	05/01/2010

Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)

Name	Address	ID/FEI	Business Operations
Establishment
MISSION VIVACARE LIMITED		677604252	API MANUFACTURE, RECOVERY

P LAX DR by