P Lax Dr
FDA Label NDC 68210-0002

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals,llc for the product P Lax Dr (NDC 68210-0002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients (in each tablet), purpose, uses, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

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

Otc - Do Not Use

Do not use for children under 6 years of age

Otc - Ask Doctor

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

Otc - Ask Doctor/Pharmacist

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

Otc - When Using

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

Otc - Stop Use

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

Otc - Pregnancy Or Breast Feeding

If pregana or breast-feeding, ask a health professional before use

Otc - Keep Out Of Reach Of Children

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)

Principal Display Panel (5mg Shipping Label)

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