Extra Gentle Laxative
- Manufacturer
- DOLGENCORP INC | TIME CAP LABORATORIES, INC.
- Effective date
- 2025-02-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 00:54:51
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
(in each tablet)
Bisacodyl USP 5 mg
OTC - PURPOSE SECTION
Purpose
Stimulant laxative
INDICATIONS & USAGE SECTION
Uses
- for temporary relief of occasional constipation and irregularity
- this product generally produces bowel movement in 6 to 12 hours
WARNINGS SECTION
Warnings
OTC - DO NOT USE SECTION
Do not use if you cannot swallow without chewing
OTC - ASK DOCTOR SECTION
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
OTC - WHEN USING SECTION
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
OTC - STOP USE SECTION
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
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.
DOSAGE & ADMINISTRATION SECTION
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
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
INACTIVE INGREDIENT SECTION
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
OTC - QUESTIONS SECTION
Questions? Call 1-888-309-9030
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEACETYLBISACODYL Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20181113 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55910-954-52 | 2025-02-10 | C162847 | 48780-1 | 2cef2736-81d6-d83d-e063-dadaa90ab31f | 14R Dollar General 55910 954 Bisacodyl Delayed-Release USP,5mg ct25 |
| 55910-954-52 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-81d6-d83d-e063-dadaa90ab31f | 14R Dollar General 55910 954 Bisacodyl Delayed-Release USP,5mg ct25 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55910-954-52 | Extra Gentle Laxative | 25 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 25 | 3 | |
| 55910-954-52 | Extra Gentle Laxative | 1 in 1 CARTON | TABLET, DELAYED RELEASE | 1 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Extra Gentle Laxative
- BISACODYL
- 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
- DEACETYLBISACODYL
- ACACIA
- CARNAUBA WAX
- FERRIC OXIDE YELLOW
- MAGNESIUM STEARATE
- POLYVINYL ACETATE PHTHALATE
- POVIDONE
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- STEARIC ACID
- SUCROSE
- TALC
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55910-954 | 55910-954-52 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Extra Gentle Laxative | BISACODYL | DOLGENCORP INC | be214c4e-f6db-cc8d-e053-2a95a90addf7 | 2025-02-10 | Warnings | 55910-954-52 55910-954 55910095452 2dc5e1a4-15c8-2120-e063-6294a90a89ab be214c4e-f6db-cc8d-e053-2a95a90addf7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
