FDA Label for P Lax Dr
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENTS (IN EACH TABLET)
- PURPOSE
- USES
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTION
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL - 5 MG SHIPPING LABEL
P Lax Dr Product Label
The following document was submitted to the FDA by the labeler of this product Spirit Pharmaceuticals,llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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"
* Please review the disclaimer below.