CORRECTOL- bisacodyl tablet, coated
Bayer HealthCare LLC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Correctol ®

Drug Facts

Active ingredient (In each tablet)

Bisacodyl 5mg

Purpose

Stimulant Laxative

Uses

for relief of occasional constipation (irregularity)
this product generally produces bowel movement in 6 to 12

Warnings

Do not use

if you are unable to swallow without chewing
within 1 hour after taking antacid or milk

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
abdominal discomfort, faintness, and cramps may occur

Stop use and ask a doctor if

you need to use more than 1 week
rectal bleeding or failure to have a bowel movement after use of a laxative. These may be signs of a serious condition

If pregnant 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

Directions

take with 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 a day
children under 6 years of age	ask a doctor

Other information

do not expose to temperatures above 30°F
store between 20 to 25°C (68 to 77°F)

Inactive ingredients

Anhydrous Lactose, Carmine, Carnauba wax, Hypromellose, Magnesium stearate, Methacrylic Acid and Ethyl Acrylate Copolymer Dispersion, Pharmaceutical Ink, Polyethylene Glycol, Polysorbate 80, Polyvinyl Alcohol, Sodium Lauryl Sulfate, Talc, Titanium Dioxide, Triacetin, Triethyl Citrate

Questions or comments?

Call 1-800-317-2165 between 8:00 AM and 5:00 PM Central Standard Time Monday through Friday.

Distributed by
MSD Consumer Care, Inc.,
PO Box 377, Memphis, TN 38151 USA,
a subsidiary of Merck & Co., Inc.,
Whitehouse Station, NJ USA.

PRINCIPAL DISPLAY PANEL - 60 Tablet Carton

NDC 11523-4335-03

The Woman's Gentle Laxative

Correctol ®

Bisacodyl Stimulant Laxative

Dependable
Overnight Relief

60
COMFORT-COATED
TABLETS

Principal Display Panel - 60 Tablet Carton

CORRECTOL
bisacodyl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11523-4335
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y)	BISACODYL	5 mg

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYVINYL ALCOHOL (UNII: 532B59J990)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	C
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11523-4335-1	1 in 1 CARTON	07/31/2014	08/30/2016
1		15 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:11523-4335-2	2 in 1 CARTON	07/31/2014	08/30/2016
2		15 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:11523-4335-3	4 in 1 CARTON	07/31/2014	08/30/2016
3		15 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC:11523-4335-4	6 in 1 CARTON	07/31/2014	08/30/2016
4		15 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	07/31/2014	08/30/2016

Labeler - Bayer HealthCare LLC. (112117283)

Name	Address	ID/FEI	Business Operations
Establishment
Rottendorf Pharma INC. (Germany)		315974691	manufacture(11523-4335)

Revised: 9/2017

Document Id: 599e653d-4e23-328d-e053-2991aa0aee17

Set id: 2c199518-ae77-40a6-82ce-3aa24a685d4a

Version: 2

Effective Time: 20170920

Bayer HealthCare LLC.