LAXATIVE

Manufacturer
Heartland Pharma Co. | Geri-Care Pharmaceutical Corp
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
monthly-update
Hydrated at
2026-06-03 17:51:08

Label at a glance#

ProductLAXATIVE
Active ingredientBISACODYL
Label structure9 sections

Indications and uses

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

Dosage and administration

take with a glass of water do not take more than directed adults and children 12 years of age and over 1-3 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

Storage and handling

store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted between 15º-30ºC (59º-86ºF) avoid excessive humidity package not child resistant

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Bisacodyl 5 mg

Purpose

OTC - PURPOSE SECTION

Stimulant Laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use if you cannot swallow without chewing
Ask a doctor before use if you have
• stomach pain, nausea, vomiting
• noticed a sudden change in bowel habits that lasts more than 2 weeks
When using this product • do not chew or crush tablet(s)
• do not use within 1 hour after taking an antacid or milk
• it may cause stomach discomfort, faintness and cramps
Stop use and ask a doctor if • you have rectal bleeding or no
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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • take with a glass of water
  • do not take more than directed
adults and children
12 years of age and over
1-3 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

Other information

STORAGE AND HANDLING SECTION

  • store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted between 15º-30ºC (59º-86ºF)
  • avoid excessive humidity
  • package not child resistant

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia, ammonium hydroxide,
calcium carbonate, corn starch, D&C yellow #10 lake,
FD&C yellow #6 lake, hypromellose, iron oxide black, lactose,
magnesium stearate, methylparaben, PEG, polydextrose,
polyvinyl acetate phthalate, propylparaben, propylene glycol,
povidone, shellac, simethicone, silica, sodium alginate,
sodium benzoate, sodium bicarbonate, stearic acid, sucrose,
talc, titanium dioxide, triacetin, triethyl citrate, wax.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-540-3765

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
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816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
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7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80136-87180136-871-73

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
45260456-6af5-6e05-e063-6294a90a394924e5689b-a5d7-479d-b7ec-c9b1d35a6df32025-12-04WarningsExact identifier
spl id: 45260456-6af5-6e05-e063-6294a90a3949
spl set id: 24e5689b-a5d7-479d-b7ec-c9b1d35a6df3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.