Kroger 151r 25 Count Blisters

Kroger 151r 25 Count Blisters
SPL v3
SPL
SPL Set ID a24fcb4b-c923-711c-e053-2a95a90a82e7
Route
ORAL
Published
Effective Date 2025-02-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Deacetylbisacodyl (5 mg)
Inactive Ingredients
Fd&c Blue No. 2 Aluminum Lake Ferric Oxide Yellow Magnesium Stearate Polyethylene Glycol 400 Povidone Sodium Starch Glycolate Type A Corn Polyvinyl Acetate Phthalate Sucrose Acacia Ferrosoferric Oxide Stearic Acid Anhydrous Lactose Carnauba Wax Starch, Corn D&c Red No. 27 Aluminum Lake Fd&c Yellow No. 6 Aluminum Lake Gelatin Ferric Oxide Red 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 2020-05-29

Description

Drug Facts


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

Drug Facts

Section 42229-5

Drug Facts

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? Call 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 42229-5 (42229-5)

Drug Facts

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? Call 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)