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P LAX DR

SPIRIT PHARMACEUTICALS,LLC

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


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients (in each tablet)

Bisacodyl 5 mg

Purpose

Stimulant laxative

P LAX DR 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

P LAX DR 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

P LAX DR

BISACODYL TABLET, SUGAR COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68210-0002
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
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 Size Shape
PINK 8 mm ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10000 in 1 BAG
2 50000 in 1 BAG
3 65000 in 1 BAG
4 70000 in 1 BAG
5 80000 in 1 BAG
6 NDC:68210-0002-8 1 in 1 DRUM

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2010-05-01


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Be sure to consult your doctor before taking any medication!
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