Leader-cardinal 151r 25 Count Blisters

Leader-cardinal 151r 25 Count Blisters
SPL v3
SPL
SPL Set ID ab34bc89-6738-d284-e053-2a95a90a5dc9
Route
ORAL
Published
Effective Date 2019-04-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Deacetylbisacodyl (5 mg)
Inactive Ingredients
Fd&c Blue No. 2 Ferric Oxide Yellow Magnesium Stearate Polyethylene Glycol 400 Povidone Sodium Starch Glycolate Type A Corn Polyvinyl Acetate Phthalate Raw Sugar Acacia Ferrosoferric Oxide Stearic Acid Anhydrous Lactose Carnauba Wax Starch, Corn D&c Red No. 27 Food Yellow 3 Free Acid Gelatin Ferrous Oxide Calcium Cation Silicon Dioxide Microcrystalline Cellulose Shellac Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: TCL Shape: round Color: pink Size: 5 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-07-24
Description

In each tablet: Bisacodyl 5mg

Medication Information

Warnings and Precautions

Warnings

Indications and Usage
  • relieves occasional constipation and irregularity
  • this product generally produces bowel movement in 6 to 12 hours

Dosage and Administration
  • take with a glass of water

adults and children 12 years and over take 1 to 3 tablets in a single daily dose

children 6 to under 12 years of age take 1 tablet in a single daily dose

children under 6 years of age ask a doctor

Description

In each tablet: Bisacodyl 5mg

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 use of a laxative. 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

  • do not chew or crush tablet(s)
  • do not use within 1 hour after taking an antacid or milk
  • you may have stomach discomfort, faintness or cramps
Section 50569-3

Ask a doctor before use if you have

  • stomach pain, nausea or vomiting
  • a sudden change in bowel habits that lasts more than two weeks

Section 50570-1

Do not useif you cannot swallow without chewing

Section 51945-4

Section 53414-9

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

Section 55105-1
Stimulant Laxative

Section 55106-9
In each tablet: Bisacodyl 5mg

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

Structured Label Content

Indications and Usage (34067-9)
  • relieves occasional constipation and irregularity
  • this product generally produces bowel movement in 6 to 12 hours

Dosage and Administration (34068-7)
  • take with a glass of water

adults and children 12 years and over take 1 to 3 tablets in a single daily dose

children 6 to under 12 years of age take 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 use of a laxative. 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

  • do not chew or crush tablet(s)
  • do not use within 1 hour after taking an antacid or milk
  • you may have stomach discomfort, faintness or cramps
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • stomach pain, nausea or vomiting
  • a sudden change in bowel habits that lasts more than two weeks

Section 50570-1 (50570-1)

Do not useif you cannot swallow without chewing

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Stimulant Laxative

Section 55106-9 (55106-9)
In each tablet: Bisacodyl 5mg

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:41.547348 · Updated: 2026-03-14T23:02:23.126471