Valumeds Laxative

Valumeds Laxative
SPL v2
SPL
SPL Set ID 6290de48-f30b-4e8d-a974-eb2cfed1d09a
Route
ORAL
Published
Effective Date 2017-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Deacetylbisacodyl (5 mg)
Inactive Ingredients
Acacia Calcium Sulfate Anhydrous Anhydrous Lactose Carnauba Wax Silicon Dioxide Starch, Corn D&c Yellow No. 10 Fd&c Yellow No. 6 Gelatin Ferrosoferric Oxide Ferric Oxide Yellow Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol 400 Polyvinyl Acetate Phthalate Povidone Shellac Sodium Starch Glycolate Type A Potato Stearic Acid Sucrose Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: TCL003 Shape: round Color: orange Size: 6 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-05-19

Description

Drug Facts

Purpose

Stimulant laxative


Medication Information

Purpose

Stimulant laxative

Description

Drug Facts

Uses
  • for temporary relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 6 to 12 hours
Section 42229-5

Drug Facts

Section 53414-9

if pregnant or breast-feeding, ask a health professional before use.

Warnings

Do not use if you cannot swallow without chewing

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

Active Ingredient

Bisacodyl (USP) 5 mg

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

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
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

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
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


Structured Label Content

Uses
  • for temporary relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 6 to 12 hours
Section 42229-5 (42229-5)

Drug Facts

Section 53414-9 (53414-9)

if pregnant or breast-feeding, ask a health professional before use.

Purpose

Stimulant laxative

Warnings

Do not use if you cannot swallow without chewing

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

Active Ingredient (Active ingredient)

Bisacodyl (USP) 5 mg

Other Information (Other information)
  • each tablet contains: magnesium 5 mg
  • store at 20-25°C (68-77°F)
  • protect from excessive humidity
Inactive Ingredients (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? (Questions or comments?)

1-888-333-9792

When Using This Product (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 (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
Keep Out of Reach of Children (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

Ask A Doctor Before Use If You Have (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
Principal Display Panel 5 Mg Tablets Bottle (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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)