BISACODYL STIMULANT LAXATIVE- bisacodyl tablet, coated

Bisacodyl by

Drug Labeling and Warnings

Bisacodyl by is a Otc medication manufactured, distributed, or labeled by Raritan Pharmaceuticals Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Bisacodyl, USP 5 mg

Purpose

Stimulant laxative

Use

• ▪ for relief of occasional constipation and irregularity
• ▪ this product generally produces a 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 or vomiting
• ▪ a sudden change in bowel habits that lasts more than 2 weeks

When using this product

• ▪ it may cause stomach discomfort, faintness and cramps
• ▪ do not chew or crush tablet(s)
• ▪ do not use within 1 hour after taking an antacid or milk

Stop use and ask a doctor if

• ▪ you have rectal bleeding or fail to have bowl movement after using this product. These could be signs of a serious condition.
• ▪ you need to use a laxative for more than 1 week

If pregnancy 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 at (1-800-222-1222).

Directions

take with a glass of water

• adults and children 12 years of age and over:

  1 to 3 tablets 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:

  ask a doctor

Other information

• store at room temperature
• Protect from excessive humidity

Inactive ingredients

acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow No. 10, FD&C yellow No. 6, gelatin, iron oxide, iron oxide black, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide.

Questions or comments?

1-866-467-2748

Principal Display Panel

NDC# 68163-116-25

*Compare to the Active Ingredient in Dulcolax® Tablets

Bisacodyl Laxative

Bisacodyl, USP 5 mg/Stimulant Laxative

Gentle, Overnight relief constipation relief

25 Coated Tablets

*This product is not manufactured or distributed by Chattem Inc., the owner of the registered trademark Dulcolax® Tablets.

TAMPER EVIDENT: Do not use if any individual unit is broken or open.

IMPORTANT: Keep this carton for future reference on full labeling.

Manufactured by:

Raritan Pharmaceuticals

8 Joanna Court,

East Brunswick, NJ 08816

INGREDIENTS AND APPEARANCE

BISACODYL  STIMULANT LAXATIVE
bisacodyl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68163-116
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
ACACIA (UNII: 5C5403N26O)
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SHELLAC (UNII: 46N107B71O)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
RAW SUGAR (UNII: 8M707QY5GH)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	RP116
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68163-116-25	1 in 1 CARTON	10/29/2019
1		25 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	10/29/2019

Labeler - Raritan Pharmaceuticals Inc (127602287)