Good

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SPL v2
SPL
SPL Set ID c8286a71-52a4-4568-a909-b04940aa4bfe
Route
ORAL
Published
Effective Date 2025-01-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Deacetylbisacodyl (5 mg)
Inactive Ingredients
Acacia Calcium Carbonate Croscarmellose Sodium D&c Yellow No. 10 Aluminum Lake Anhydrous Dibasic Calcium Phosphate Fd&c Yellow No. 6 Aluminum Lake Gelatin, Unspecified Glyceryl Monostearate Hypromellose, Unspecified Ferric Oxide Red Magnesium Stearate Methacrylic Acid And Ethyl Acrylate Copolymer Microcrystalline Cellulose Polyethylene Glycol, Unspecified Silicon Dioxide Methylparaben Sodium Propylparaben Sodium Sodium Starch Glycolate Type A Starch, Corn Sucrose Talc Titanium Dioxide Triethyl Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-10

Description

Bisacodyl (USP) 5 mg

Purpose

Stimulant laxative


Medication Information

Purpose

Stimulant laxative

Description

Bisacodyl (USP) 5 mg

Use

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

Section 42229-5

Compare to the active ingredient of Dulcolax ® Laxative Tablets*

Gentle, dependable constipation relief

*This product is not manufactured or distributed by Sanofi-Aventis Deutschland GMBH, owner of the registered trademark Dulcolax® Laxative Tablets.

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

DISTRIBUTED BY:

Strive Pharmaceuticals, Inc.

East Brunswick, NJ 08816

Product of India

Section 50565-1

Keep out of reach of children.

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

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 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 a laxative for more than 1 week

If pregnant or breast-feeding, ask a health professional before use.

Packaging

Directions

• do not take 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. It is recommended to start with the lowest dose (1 tablet) increasing the next day as needed
children 6 to under 12 years of age 1 tablet in a single daily dose
children under 6 years ask a doctor

Drug Facts

Other Information

• contains FD&C yellow no. 6

• store at 20°C- 25°C (68°-77°F)

• protect from excessive humidity

Inactive Ingredients

acacia gum, calcium carbonate, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate, FD&C yellow #6 aluminum lake, gelatin, glycerol monostearate, hypromellose, iron oxide red, magnesium stearate, methacrylic acid co-polymer type C, microcrystalline cellulose, polyethylene glycol, precipitated silica, silicon dioxide, sodium methylparaben, sodium propylparaben, sodium starch glycolate, starch, sucrose, talcum, titanium dioxide, triethyl citrate

Questions Or Comments?

1-888-577-8033 Monday-Friday 8am - 4pm EST

Active Ingredient (in Each Tablet)

Bisacodyl (USP) 5 mg


Structured Label Content

Use

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

Section 42229-5 (42229-5)

Compare to the active ingredient of Dulcolax ® Laxative Tablets*

Gentle, dependable constipation relief

*This product is not manufactured or distributed by Sanofi-Aventis Deutschland GMBH, owner of the registered trademark Dulcolax® Laxative Tablets.

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

DISTRIBUTED BY:

Strive Pharmaceuticals, Inc.

East Brunswick, NJ 08816

Product of India

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Purpose

Stimulant laxative

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 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 a laxative for more than 1 week

If pregnant or breast-feeding, ask a health professional before use.

Packaging

Directions

• do not take 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. It is recommended to start with the lowest dose (1 tablet) increasing the next day as needed
children 6 to under 12 years of age 1 tablet in a single daily dose
children under 6 years ask a doctor

Drug Facts

Other Information (Other information)

• contains FD&C yellow no. 6

• store at 20°C- 25°C (68°-77°F)

• protect from excessive humidity

Inactive Ingredients (Inactive ingredients)

acacia gum, calcium carbonate, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate, FD&C yellow #6 aluminum lake, gelatin, glycerol monostearate, hypromellose, iron oxide red, magnesium stearate, methacrylic acid co-polymer type C, microcrystalline cellulose, polyethylene glycol, precipitated silica, silicon dioxide, sodium methylparaben, sodium propylparaben, sodium starch glycolate, starch, sucrose, talcum, titanium dioxide, triethyl citrate

Questions Or Comments? (Questions or comments?)

1-888-577-8033 Monday-Friday 8am - 4pm EST

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Bisacodyl (USP) 5 mg


Advanced Ingredient Data


Raw Label Data

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