BISACODYL tablet, delayed release

Bisacodyl by

Drug Labeling and Warnings

Bisacodyl by is a Otc medication manufactured, distributed, or labeled by Apnar Pharma LP, Apnar Pharma Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Bisacodyl (USP) 5 mg

PURPOSE

Purpose

Stimulant laxative

INDICATIONS & USAGE

​Uses

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

WARNINGS

Warnings

Do not use

• if you cannot swallow without chewing

Ask a doctor before use if you have:

• stomach pain, nausea, or vomiting
• noticed 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 tablets(s)
• do not use within 1 hour after taking 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 a laxative for more than 1 week

If pregnant or breast-feeding,

ask a health care professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• take with glass of water
• adult 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

STORAGE AND HANDLING

Other Information

• store at 15º-30ºC (59º - 86º F).

INACTIVE INGREDIENT

Inactive ingredients

Lactose monohydrate, Anhydrous lactose, Pregelatinized starch, Magnesium stearate, Hypromellose, Triacetin, Talc, Methacrylic acid-ethyl acrylate copolymer (1:1) Type-A, Titanium dioxide, Triethyl citrate, D&C red no. 27, Colloidal anhydrous silica, Sodium bicarbonate, Sodium lauryl sulfate, FD&C blue no. 1, Carboxymethyl cellulose sodium, Maltodextrin, Dextrose monohydrate, Lecithin Soya.

QUESTIONS

Questions or comments?

• 1-855-642-2594

SPL UNCLASSIFIED SECTION

Distributed By:

APNAR PHARMA LP

CHINO, CA, 91710

Rev.: 07/2022

Compare to Dulcolax Pink®

active ingredient*

*This product is not maufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., owner of the registered trademark of Dulcolax Pink ®

BOXED WARNING

(What is this?)

Caution: Do not use if imprinted seal under cap is broken or missing.

PRINCIPAL DISPLAY PANEL

NDC: 24689-129-02

Bisacodyl Delayed Release Tablets USP

5 mg- Pink

Stimulant Laxative

20 Tablets

NDC: 24689-129-03

Bisacodyl Delayed Release Tablets USP

5 mg- Pink

Stimulant Laxative

100 Tablets

NDC: 24689-129-04

Bisacodyl Delayed Release Tablets USP

5 mg- Pink

Stimulant Laxative

250 Tablets

NDC: 24689-129-05

Bisacodyl Delayed Release Tablets USP

5 mg- Pink

Stimulant Laxative

500 Tablets

INGREDIENTS AND APPEARANCE

BISACODYL 
bisacodyl tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24689-129
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
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)
TRIACETIN (UNII: XHX3C3X673)
D&C RED NO. 27 (UNII: 2LRS185U6K)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
METHACRYLIC ACID-ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
TALC (UNII: 7SEV7J4R1U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	F
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24689-129-02	20 in 1 BOTTLE; Type 0: Not a Combination Product	11/21/2022
2	NDC: 24689-129-03	100 in 1 BOTTLE; Type 0: Not a Combination Product	11/21/2022
3	NDC: 24689-129-04	250 in 1 BOTTLE; Type 0: Not a Combination Product	11/21/2022
4	NDC: 24689-129-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	11/21/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	11/21/2022

Labeler - Apnar Pharma LP (079568229)

Establishment
Name	Address	ID/FEI	Business Operations
Apnar Pharma Private Limited		876730408	manufacture(24689-129) , pack(24689-129) , analysis(24689-129)