151r_albertsons_21130-555_bisacodyl Usp 5 Mg-stimulant Laxative

151r_albertsons_21130-555_bisacodyl Usp 5 Mg-stimulant Laxative
SPL v3
SPL
SPL Set ID f2c4ed1a-5aa4-1915-e053-2a95a90a59b6
Route
ORAL
Published
Effective Date 2023-07-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Deacetylbisacodyl (5 mg)
Inactive Ingredients
Calcium Sulfate Anhydrous Sodium Starch Glycolate Type A Corn Ferric Oxide Red Stearic Acid Titanium Dioxide Povidone D&c Red No. 27 Aluminum Lake Anhydrous Lactose Fd&c Blue No. 2 Aluminum Lake Carnauba Wax Gelatin Acacia Silicon Dioxide Ferric Oxide Yellow Starch, Corn Polyethylene Glycol, Unspecified Shellac Sucrose Talc Ferrosoferric Oxide Fd&c Yellow No. 6 Aluminum Lake Microcrystalline Cellulose Polyvinyl Acetate Phthalate Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: TCL Shape: round Color: pink Size: 6 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-10

Description

Active ingredient (in each tablet) Bisacodyl USP, 5 mg


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

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

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

Description

Active ingredient (in each tablet) Bisacodyl USP, 5 mg

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50566-9

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
Section 50567-7

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
Section 50569-3

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
Section 50570-1

Do not use

  • if you cannot swallow without chewing
Section 51727-6

Inactive ingredients acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, iron oxide, iron oxide black, iron oxide yellow (iron oxide ochre), magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide

Section 51945-4

Section 53413-1

Questions or comments?

1-877-290-4008

Section 53414-9

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

Section 55105-1

Purpose

Stimulant laxative

Section 55106-9

Active ingredient (in each tablet)

Bisacodyl USP, 5 mg

Section 60561-8

Other information

  • each tablet contains: magnesium 5 mg
  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package
  • protect from excessive humidity

Structured Label Content

Indications and Usage (34067-9)

Uses

  • for relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 6-12 hours
Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings

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 (1-800-222-1222).

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

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
Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

Do not use

  • if you cannot swallow without chewing
Section 51727-6 (51727-6)

Inactive ingredients acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, iron oxide, iron oxide black, iron oxide yellow (iron oxide ochre), magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

1-877-290-4008

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Stimulant laxative

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Bisacodyl USP, 5 mg

Section 60561-8 (60561-8)

Other information

  • each tablet contains: magnesium 5 mg
  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package
  • protect from excessive humidity

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)