Y LAX DR- bisacodyl tablet, sugar coated

Y LAX DR by

Drug Labeling and Warnings

Y LAX DR by is a Otc medication manufactured, distributed, or labeled by SPIRIT PHARMACEUTICALS,LLC, MISSION VIVACARE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 if you cannot swallow without chewing

Ask a doctor before use if you have

• Stomach 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
• it may cause stomach discomfort,faintness, and cramps

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

take with a glass of water

• 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

• store between 20° to 25°C (68° to 77° F)
• protection from excessive humidity

Inactive ingredients

lactose,cornstarch,povidone (K-30),sodium startch glycolate,talc,magnesium stearate,methacrylic acid copolymer,polethylene glaycol,sodium hydroxide pellets, sucrose,acacia,gelatin,methylparaben, propylparaben, calcium sulphate dihydrate,titanium dioxide,D&C yellow #6 lake, FD & C yellow #10; pharmaceuticals glaze

PRINCIPAL DISPLAY PANEL - 5 mg Shipping Label

Y LAX TABLETS DR, 5 mg-SUGAR COATED: YELLOW

Each Delayed Release Tablet Contains

(Bisacodyl 5 mg Tablets,USP)

LOT NO :
DRUM NO :
MFG. DATE :

QUANTITY : 50000
NDC NO : 68210-0001-5
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

Y LAX DR 
bisacodyl tablet, sugar coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-0001
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 YELLOW NO. 6 (UNII: H77VEI93A8)
ALUMINUM OXIDE (UNII: LMI26O6933)

Product Characteristics
Color	YELLOW (ORANGE YELLOW)	Score	no score
Shape	ROUND	Size	4mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68210-0001-5	1 in 1 DRUM
1		50000 in 1 BAG
2	NDC: 68210-0001-2	1 in 1 DRUM
2		250000 in 1 BAG
3	NDC: 68210-0001-3	1 in 1 DRUM
3		300000 in 1 BAG
4	NDC: 68210-0001-4	1 in 1 DRUM
4		350000 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)

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