489 - Laxative

Manufacturer
Allegiant Health
Effective date
2026-06-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-08-04 03:32:41

Label at a glance#

ProductLaxative
Active ingredientDEACETYLBISACODYL
Label structure9 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Bisacodyl USP 5 mg

Purpose

OTC - PURPOSE SECTION

Stimulant Laxative

Use(s)

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

if you cannot swallow without chewing

Ask a doctor before use if you

OTC - ASK DOCTOR SECTION

  • stomach pain, nausea or vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

When using this product

OTC - WHEN USING SECTION

  • 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 and cramps

Stop use and ask a doctor before use if

OTC - STOP USE SECTION

  • 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

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Other information

SPL UNCLASSIFIED SECTION

  • store at 25ºC (77ºF); excursions permitted between 15º to 30ºC (59º to 86ºF)
  • avoid excessive humidity
  • do not use if imprinted safety seal under cap is broken or missing
  • do not use if blister unit is broken or torn

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acacia, Calcium Carbonate, Carnauba Wax, Colloidal
Anhydrous Silica, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake,
Hypromellose, Iron Oxide Black, Lactose Anhydrous, Magnesium Stearate, Methacrylic
Acid and Ethyl Acrylate Copolymer, Methylparaben, Polydextrose, Polyethylene Glycol,
Povidone, Pregelatinized Starch, Propylene Glycol, Propylparaben, Shellac Glaze,
Simethicone, Sodium Benzoate, Sodium Bicarbonate, Sodium Lauryl Sulfate, Stearic
Acid, Sucrose, Talc, Titanium Dioxide, Triacetin, Triethyl Citrate.

Questions/Comments

OTC - QUESTIONS SECTION

Call 1-888-952-0050

(Monday-Friday 9 AM – 5 PM EST)

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Laxative
Laxative

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130369168226036GTIN-13: 0369168226036
EAN-13: 0369168226036
GTIN-12: 369168226036
UPC-A: 369168226036
GTIN storage (14 digits): 00369168226036
489---laxative-1.jpg

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69168-48969168-489-03, 69168-489-32, 69168-489-92

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 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
LaxativeLAXATIVEAllegiant Health596b11de-cf17-4c55-8638-49f387e5fac42026-06-09WarningsExact identifier
ndc (package): 69168-489-03
ndc (package): 69168-489-92
ndc (package): 69168-489-32
ndc (product): 69168-489
ndc11 (package): 69168048932
ndc11 (package): 69168048992
ndc11 (package): 69168048903
spl id: 364d3ed4-210a-4e17-94e2-0add8116a2ac
spl set id: 596b11de-cf17-4c55-8638-49f387e5fac4

Reported adverse events (FAERS/openFDA)#

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