![P LAX DR (BISACODYL) TABLET, SUGAR COATED [SPIRIT PHARMACEUTICALS,LLC]](https://medic.hrt.org//dailymed/images/f8c02e1f-4b88-47fc-a720-91deb6a89f52/bisacodyl-01.jpg)
| NDC | 68210-0002-1, 68210-0002-5, 68210-0002-6, 68210-0002-7, 68210-0002-8 |
| Set ID | f8c02e1f-4b88-47fc-a720-91deb6a89f52 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | SPIRIT PHARMACEUTICALS,LLC |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART334 |
- SPL UNCLASSIFIED SECTION
- Active ingredients (in each tablet)
- Purpose
- Uses
- for relief of occasional constipation(irregularity)
- this product generally produces bowel movement in 6 to 12 hours
- Warnings
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
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
CloseKeep 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
Closeadults 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
Close - 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 CHILDRENSTORE CONTROLLED ROOM TEMPRATURE OF 59° – 86°F (15° – 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZINGTHIS 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 THEREUNDERMANUFACTURED BY:
LABELLER CODE : 50654
LIC NO. : 25/5/2009MANUFACTURED FOR:
SPIRIT PHARMACEUTICALS LLC
225 LINCOLN HWY, STE 205
FAIRLESS HILLS , PA 19030
PH.# 215 943 4000, FAX.#215 943 4039CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"
Close
- INGREDIENTS AND APPEARANCE
P LAX DR
bisacodyl tablet, sugar coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-0002 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISACODYL (UNII: 10X0709Y6I) (BISACODYL - UNII:10X0709Y6I) BISACODYL 5 mg Inactive Ingredients Ingredient Name Strength 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) Product Characteristics Color PINK Score no score Shape ROUND Size 8mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68210-0002-1 1 in 1 DRUM 1 10000 in 1 BAG 2 NDC:68210-0002-5 1 in 1 DRUM 2 50000 in 1 BAG 3 NDC:68210-0002-6 1 in 1 DRUM 3 65000 in 1 BAG 4 NDC:68210-0002-7 1 in 1 DRUM 4 70000 in 1 BAG 5 NDC:68210-0002-8 1 in 1 DRUM 5 80000 in 1 BAG 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) CloseEstablishment Name Address ID/FEI Business Operations MISSION VIVACARE LIMITED 677604252 API MANUFACTURE, RECOVERY