Quality Choice Gentle Laxative 25 Tablets

Quality Choice Gentle Laxative 25 Tablets
SPL v6
SPL
SPL Set ID bcd3c07d-bd83-4452-9736-35c85db30c15
Route
ORAL
Published
Effective Date 2019-04-26
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, Unspecified Ferrosoferric Oxide Ferric Oxide Red Ferric Oxide Yellow Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol 400 Polyvinyl Acetate Phthalate Povidone, Unspecified Shellac Sodium Starch Glycolate Type A Potato Stearic Acid Sucrose Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: RP116 Shape: round Color: orange Size: 6 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-04-19

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.

Product Label
Other Information
  • store at 20-25ºC (68º-77ºF)
  • 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, 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?

1-866-467-2748

Principal Display Panel

NDC# 63868-908-25

*Compare to the Active Ingredient in Dulcolax®

Gentle Laxative

Relieves Constipation & Irregularity

Bisacodyl, USP 5 mg

Relieves Constipation And Irregularity Overnight

Comfort-Coated Tablets For Gentle, Predictable Constipation Relief

25 TABLETS

100% QC SATISFACTION GURANTEED

*This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., the owner of the registered trademark Dulcolax®.

TAMPER EVIDENT: DO NOT USE IF any individual unit is broken or open.

Distributed by C.D.M.A., Inc.

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questions: 248-449-9300

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. (1-800-222-1222).

If Pregnancy 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.

Product Label
Other Information (Other information)
  • store at 20-25ºC (68º-77ºF)
  • 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, 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?)

1-866-467-2748

Principal Display Panel

NDC# 63868-908-25

*Compare to the Active Ingredient in Dulcolax®

Gentle Laxative

Relieves Constipation & Irregularity

Bisacodyl, USP 5 mg

Relieves Constipation And Irregularity Overnight

Comfort-Coated Tablets For Gentle, Predictable Constipation Relief

25 TABLETS

100% QC SATISFACTION GURANTEED

*This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., the owner of the registered trademark Dulcolax®.

TAMPER EVIDENT: DO NOT USE IF any individual unit is broken or open.

Distributed by C.D.M.A., Inc.

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questions: 248-449-9300

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. (1-800-222-1222).

If Pregnancy Or Breast Feeding, (If pregnancy 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

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