Y Lax Dr (Bisacodyl) Tablet, Sugar Coated [Spirit Pharmaceuticals,llc] -

Y LAX DR (BISACODYL) TABLET, SUGAR COATED [SPIRIT PHARMACEUTICALS,LLC]
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Drug Facts
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Active ingredients (in each tablet)

Bisacodyl 5 mg
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Purpose

Stimulant laxative
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Uses
- for relief of occasional constipation(irregularity)
- this product generally produces bowel movement in 6 to 12 hours
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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.

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take with a glass of water

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
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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
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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"

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Y LAX DR
bisacodyl tablet, sugar coated

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BISACODYL (UNII: 10X0709Y6I) (BISACODYL - UNII:10X0709Y6I)	BISACODYL	5 mg

Ingredient Name	Strength
Inactive Ingredients
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)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	05/01/2010

Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)

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

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