Active Ingredients And Purpose
Active ingredient (in each tablet)
Bisacodyl (USP) 5 mg
Purpose
Stimulant laxative
VALUMEDS LAXATIVE
- Set ID
- 6290de48-f30b-4e8d-a974-eb2cfed1d09a
- Manufacturer
- SPIRIT PHARMACEUTICALS LLC | TIME-CAP LABS, INC.
- Effective date
- 2019-12-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:02:22
Key Label Information
Uses
Uses
for temporary relief of occasional constipation and irregularity this product generally produces bowel movement in 6 to 12 hours
Warnings
Warnings
Do not use if you cannot swallow without chewing
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
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
if pregnant or breast-feeding, ask a health professional before use.
Directions And Dosage
Directions
take with a glass of water adults and children 12 years 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 Label Information
Other information
each tablet contains: magnesium 5 mg store at 20-25°C (68-77°F) protect from excessive humidity
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
Questions or comments?
1-888-333-9792
PRINCIPAL DISPLAY PANEL - 5 mg tablets bottle
VALUMEDS Compare to the active ingredient in DULCOLAX®* Laxative BISACODYL USP 5 mg Gentle Overnight Relief 100 TABLETS
Products
- DEACETYLBISACODYL
NDC Codes
Ingredients
| Name | UNII | Kind |
|---|---|---|
| ACACIA | 5C5403N26O | IACT |
| CALCIUM SULFATE ANHYDROUS | E934B3V59H | IACT |
| ANHYDROUS LACTOSE | 3SY5LH9PMK | IACT |
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| GELATIN | 2G86QN327L | IACT |
| FERROSOFERRIC OXIDE | XM0M87F357 | IACT |
| FERRIC OXIDE YELLOW | EX438O2MRT | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| POLYVINYL ACETATE PHTHALATE | 58QVG85GW3 | IACT |
| POVIDONE | FZ989GH94E | IACT |
| SHELLAC | 46N107B71O | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| SUCROSE | C151H8M554 | IACT |
| TALC | 7SEV7J4R1U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| BISACODYL | 10X0709Y6I | ACTIB |
Complete SPL Sections
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each tablet)
Bisacodyl (USP) 5 mg
Purpose
Stimulant laxative
Uses
for temporary relief of occasional constipation and irregularity this product generally produces bowel movement in 6 to 12 hours
Warnings
Do not use if you cannot swallow without chewing
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
When using this product
do not chew or crush tablet(s) it may cause stomach discomfort, faintness and cramps do not use within 1 hour after taking an antacid or milk
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
if pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away 1(800)222-1222
Directions
take with a glass of water adults and children 12 years 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
each tablet contains: magnesium 5 mg store at 20-25°C (68-77°F) protect from excessive humidity
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
Questions or comments?
1-888-333-9792
SPL UNCLASSIFIED SECTION
Distributed By Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779
PRINCIPAL DISPLAY PANEL - 5 mg tablets bottle
VALUMEDS Compare to the active ingredient in DULCOLAX®* Laxative BISACODYL USP 5 mg Gentle Overnight Relief 100 TABLETS
Source Document
Official SPL XML cached by FDA.report · DailyMed PDF
- XML object
- dailymed/6290de48-f30b-4e8d-a974-eb2cfed1d09a/9aa3a56c-543b-325b-e053-2995a90ae86e.xml
- XML SHA-256
- 8e7177e8d3e00504eb4de0b4417ccf1d9c831df624cb8598b52ecdf1d11fb66f
- XML bytes
- 30214
Legacy File Index
| Folder | File | Date |
|---|---|---|
| otc | 9aa3a56c-543b-325b-e053-2995a90ae86e.xml | 2019-12-27 |
| otc | 4fa958d5-1037-0a2c-e054-00144ff88e88.xml | 2017-05-19 |
| otc | VM Bisacodyl Tablets 5mg 100ct_441-01.jpg | 2017-05-19 |