STIMULANT LAXATIVE- bisacodyl tablet, delayed release

stimulant laxative by

Drug Labeling and Warnings

stimulant laxative by is a Otc medication manufactured, distributed, or labeled by BIONPHARMA INC., Ocean Healthcare Pvt Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Bisacodyl USP, 5 mg

Purpose

Stimulant laxative

Uses

■ for relief of occasional constipation and irregularity
■ this product generally produces bowel movement in 6 to 12 hours

Warnings

Allergy alert: Contains FD&C Yellow No. 5 (tartrazine) as a color additive.

Do not use

■ if you cannot swallow without chewing

Ask a doctor before use if you have

■ abdominal pain, nausea or vomiting ■ noticed a sudden change in bowel habits that persists over a period of 2 weeks

Ask a doctor or pharmacist before use if you are

■ taking any other drug

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 a bowel movement after using this product. These could be signs of a serious condition.
■ you need to use for a period longer than 1 week

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

■ do not use more than directed
■ 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 20°-25°C (68°-77°F)
■ protect from excessive humidity

Inactive ingredients

colloidal silicon dioxide, FD&C yellow #5 (tartrazine), FD&C yellow #6, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and methyl methacrylate copolymer, microcrystalline cellulose, pharmaceutical imprinting ink, sodium starch glycolate, talc, titanium dioxide, triacetin, triethyl citrate

Questions?

call 1-888-235-2466

300's count

* compare to the active ingredient in Dulcolax® Laxative

a+ health TM

stimulant laxative

bisacodyl delayed-release
tablets USP, 5 mg

gentle, dependable
constipation relief

300 tablets

enteric coated tablets

INGREDIENTS AND APPEARANCE

STIMULANT LAXATIVE 
bisacodyl tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69452-541
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
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
MAGNESIUM STEARATE (UNII: 70097M6I30)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND (circular)	Size	5mm
Flavor		Imprint Code	0
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69452-541-83	300 in 1 BOTTLE; Type 0: Not a Combination Product	02/23/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	02/23/2026

Labeler - BIONPHARMA INC. (079637826)

Registrant - BIONPHARMA INC. (079637826)

Establishment
Name	Address	ID/FEI	Business Operations
Ocean Healthcare Pvt Ltd		873673519	manufacture(69452-541)