Gentle Laxative

Gentle Laxative
SPL v2
SPL
SPL Set ID bf173818-8f8c-43a0-9c89-095aec13d046
Route
ORAL
Published
Effective Date 2020-03-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Deacetylbisacodyl (5 mg)
Inactive Ingredients
Acacia Calcium Sulfate Anhydrous Carnauba Wax Silicon Dioxide Starch, Corn D&c Red No. 27 Aluminum Lake Fd&c Blue No. 2 Ferric Oxide Red Ferrosoferric Oxide Ferric Oxide Yellow Fd&c Yellow No. 6 Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol 400 Povidone Shellac Sodium Starch Glycolate Type A Corn Stearic Acid Sucrose Talc Titanium Dioxide Polyvinyl Acetate Phthalate Gelatin Anhydrous Lactose

Identifiers & Packaging

Pill Appearance
Imprint: TCL Shape: round Color: pink Size: 6 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-12

Description

Bisacodyl USP 5 mg

Purpose

Stimulant laxative


Medication Information

Purpose

Stimulant laxative

Description

Bisacodyl USP 5 mg

Use
  • for temporary relief of occasional constipation and irregularity
  • this product generally produces a bowel movement in 6 to 12 hours
Directions
  • 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
Do Not Use

if you cannot swallow without chewing.

Other Information
  • each tablet contains: magnesium 5 mg
  • store between 20-25ºC (68-77ºF)
Inactive Ingredients

acacia, calcium sulfate anhydrous, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C red # 27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, iron oxide, iron oxide black, iron oxide yellow,  magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide

Questions Or Comments?

 Call 1-888-309-9030

Principla Display Panel

Compare to active ingredient of Dulcolax® Pink® Laxative*

Women's Gentle Laxative Tablets

Bisacodyl 5 mg

Stimulant laxative

Gentle, Overnight relief

*This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., distributor or Dulcolax® Pink® Laxative

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

When Using This Product
  • do not chew or crush tablet(s)
  • do not use within 1 hour after taking an antacid or milk
  • it may cause stomach discomfort, faintness and cramps
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.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredient (in Each Tablet)

Bisacodyl USP 5 mg

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

Structured Label Content

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

Stimulant laxative

Directions
  • 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
Do Not Use (Do not use)

if you cannot swallow without chewing.

Other Information (Other information)
  • each tablet contains: magnesium 5 mg
  • store between 20-25ºC (68-77ºF)
Inactive Ingredients (Inactive ingredients)

acacia, calcium sulfate anhydrous, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C red # 27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, iron oxide, iron oxide black, iron oxide yellow,  magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

 Call 1-888-309-9030

Principla Display Panel (PRINCIPLA DISPLAY PANEL)

Compare to active ingredient of Dulcolax® Pink® Laxative*

Women's Gentle Laxative Tablets

Bisacodyl 5 mg

Stimulant laxative

Gentle, Overnight relief

*This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., distributor or Dulcolax® Pink® Laxative

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

When Using This Product (When using this product)
  • do not chew or crush tablet(s)
  • do not use within 1 hour after taking an antacid or milk
  • it may cause stomach discomfort, faintness and cramps
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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Bisacodyl USP 5 mg

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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)