FDA.reportPublic FDA data

Gentle Laxative

Manufacturer
Healthlife of USA | Time Cap Laboratiries, Inc.
Effective date
2021-10-10
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 22:33:34

Label at a glance#

ProductGentle Laxative
Active ingredientBISACODYL
Label structure15 sections

Indications and uses

For temporary relief of occasional constipation and irregularity This product generally produces a bowel movement in 6 to 12 hours

Dosage and administration

Take with a glass of water  Adults and children 12 years of age 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

Label contents#

Full prescribing information#

Drug Facts

OTC - PURPOSE SECTION

Gentle Laxative 

Purpose 

OTC - PURPOSE SECTION

Stimulant Laxative

Active Ingerient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Bisacodyl 5mg

Uses

INDICATIONS & USAGE SECTION

  • For temporary relief of occasional constipation and irregularity
  • This product generally produces a 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

OTC - ASK DOCTOR SECTION

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

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 
  • It may cause stomach discomfirt, faintness and cramps

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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

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 right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Take with a glass of water 
  • Adults and children 12 years of age 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

Other Information

OTC - QUESTIONS SECTION

  • Store at controlled room temperature 20°- 25°C  (68°- 77°F)
  • Read all product information before using 
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING 

Inactive ingredients

INACTIVE INGREDIENT SECTION

  • Colloidal silicon dioxide
  • Croscarmellose sodium
  • Dicalcium phosphate 
  • FD&C Blue#1
  • FD&C Blue#2
  • Magnesium Stearate
  • Microcrystalline cellulose
  • Polyethylene glycol
  • Polyvinyl alcohol
  • Talc
  • Titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-844-832-1138 Monday through Friday 9AM - 5PM EST or www.healthlifeofusa.com

Gentle Laxative Bisacodyl 5 mgCompare to Dulcolax® Laxative active ingredients Distributed by: Healthlife of USA LLCRahwayNJ 07065www.healthlifeofusa.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gentle laxativeGentle laxative

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69517-116-242024-06-13C16284748780-1f386c649-a85d-0266-e053-dadaa90a7c1aGentle Laxative Bisacodyl 5mg
69517-116-242023-01-30C16284748780-1f386c649-a85d-0266-e053-dadaa90a7c1aGentle Laxative Bisacodyl 5mg

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69517-11669517-116-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
BISACODYL10X0709Y6IACTIB

Source Document#

Source XML · Source PDF

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
085b53ab-db53-b15b-e063-6394a90a51e70e440fc9-4ee6-48cd-9191-245d86f309ca2024-06-13WarningsExact identifier
spl set id: 0e440fc9-4ee6-48cd-9191-245d86f309ca

Reported adverse events (FAERS/openFDA)#

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