CARTERS LITTLE PILLS SODIUM-FREE - bisacodyl tablet, delayed release
Church & Dwight Co., Inc.

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.

----------

Active ingredient (in each tablet)

Bisacodyl USP, 5 mg

Purpose

Stimulant laxative

Uses

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

Warnings

Do not use

in children under 6 years of age
if your can't swallow without chewing
for a period longer than 1 week, unless directed by a doctor

Ask a doctor before use if you have

stomach pain, nausea, or vomiting
a sudden change in bowel habits that persists over 2 weeks

When using this product

do not use within 1 hour after taking an antacid or milk
do not chew or crush tablets
you may have stomach discomfort, faintness and cramps

Stop use and ask a doctor if

you need to use a laxative for more than 1 week
you fail to have a bowel movement or have rectal bleeding. These could be signs of a serious condition.

Keep out of reach of children.

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

Follow dosage below or use a directed by a doctor

adults and children 12 years of age and over                                    1 to 3 tablets (usually 2) in a single daily dose
children 6 to under 12 years of age                                                  1 tablet in a single daily dose
children under 6 years of age                                                           consult a doctor

Other information

avoid excessive humidity
store at temperatures not above 86 degrees F (30 C)

Questions or Comments: 1-800-926-5222 M-F from 9-5 ET

Inactive ingredients

Croscarmellose Sodium, Hydroxypropyl Methylcellulose, Lactose, Magnesium Stearate, Methacrylic Acid Copolymer, Microcrystalline Cellulose, Talc, Triacetin, Triethyl Citrate, Zea mays (Corn) Starch

Principal Display

Overnight Relief Guaranteed

CARTERS
LITTLE
PILLS

Carter's
BISACODYL DELAYED-RELEASED TABLETS
STIMULANT LAXATIVE

Sodium-Free

ENTERIC COATED 25 TABLETS

Carton image

CARTERS LITTLE PILLS SODIUM-FREE
bisacodyl tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10237-906
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISACODYL (BISACODYL)	BISACODYL	5 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2208 (100 MPA.S)
LACTOSE
MAGNESIUM STEARATE
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
TALC
TRIETHYL CITRATE

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	C;5
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:10237-906-25	1 BLISTER PACK ( BLISTER PACK) in 1 CARTON	contains a BLISTER PACK
1		25 TABLET, DELAYED RELEASE ( TABLET) in 1 BLISTER PACK	This package is contained within the CARTON (10237-906-25)
2	NDC:10237-906-75	3 BLISTER PACK ( BLISTER PACK) in 1 CARTON	contains a BLISTER PACK
2		25 TABLET, DELAYED RELEASE ( TABLET) in 1 BLISTER PACK	This package is contained within the CARTON (10237-906-75)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	06/01/2011

Labeler - Church & Dwight Co., Inc. (001211952)

Establishment
Name	Address	ID/FEI	Operations
Church & Dwight Canada Corp.		253620736	manufacture

Establishment
Name	Address	ID/FEI	Operations
Ultra Seal Corporation		085752004	repack

Revised: 06/2010 Church & Dwight Co., Inc.