14r Dollar General 55910 954 Bisacodyl Delayed-release Usp,5mg Ct25

14r Dollar General 55910 954 Bisacodyl Delayed-release Usp,5mg Ct25
SPL v3
SPL
SPL Set ID be214c4e-f6db-cc8d-e053-2a95a90addf7
Route
ORAL
Published
Effective Date 2021-07-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Deacetylbisacodyl (5 mg)
Inactive Ingredients
Calcium Sulfate Anhydrous Starch, Corn D&c Yellow No. 10 Aluminum Lake Fd&c Yellow No. 6 Aluminum Lake Silicon Dioxide Polyethylene Glycol 400 Anhydrous Lactose Gelatin Ferric Oxide Red Ferrosoferric Oxide Microcrystalline Cellulose Shellac Acacia Carnauba Wax Ferric Oxide Yellow Magnesium Stearate Polyvinyl Acetate Phthalate Povidone Sodium Starch Glycolate Type A Potato Stearic Acid Sucrose Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: TCL003 Shape: round Color: orange Size: 5 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-07-24

Description

Active ingredient (in each tablet) Bisacodyl USP 5 mg


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

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

Dosage and Administration

Directions

  • 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

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.

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 discomtort, 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 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 yellow #10 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? Call 1-888-309-9030

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

Other Information

Other information

  • each tablet contains: magnesium 5 mg
  • store at 25 0C (77 0F) excursions permitted between 15 0C-30 0C (59 0-86 0F)
  • use by expiration date on package
  • protect from excessive humidity


Structured Label Content

Indications and Usage (34067-9)

Uses

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

Dosage and Administration (34068-7)

Directions

  • 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.

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 discomtort, 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 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 yellow #10 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? Call 1-888-309-9030

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

Other Information (OTHER INFORMATION)

Other information

  • each tablet contains: magnesium 5 mg
  • store at 25 0C (77 0F) excursions permitted between 15 0C-30 0C (59 0-86 0F)
  • use by expiration date on package
  • protect from excessive humidity


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)