Drx. Choice ®

Drx. Choice ®
SPL v7
SPL
SPL Set ID b99c1a6d-3034-4822-8540-210179c06857
Route
ORAL
Published
Effective Date 2025-09-26
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 Raw Sugar 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 2019-10-29

Description

Bisacodyl, USP 5 mg

Purpose

Stimulant laxative


Medication Information

Purpose

Stimulant laxative

Description

Bisacodyl, USP 5 mg

Use
  • for 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 

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

Do Not Use

if you cannot swallow without chewing.

Other Information
  • store at room temperature
  • Protect from excessive humidity
Inactive Ingredients

acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow No. 10, FD&C yellow No. 6, 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# 68163-116-25

*Compare to the Active Ingredient in Dulcolax® Tablets

Bisacodyl Laxative

Bisacodyl, USP 5 mg/Stimulant Laxative

Gentle, Overnight relief constipation relief

25 Coated Tablets

*This product is not manufactured or distributed by Chattem Inc., the owner of the registered trademark Dulcolax® Tablets.

TAMPER EVIDENT: Do not use if any individual unit is broken or open.

IMPORTANT:Keep this carton for future reference on full labeling.

Manufactured by:

Raritan Pharmaceuticals

8 Joanna Court,

East Brunswick, NJ 08816

When Using This Product
  • it may cause stomach discomfort, faintness and cramps
  • do not chew or crush tablet(s)
  • do not use within 1 hour after taking an antacid or milk
Stop Use and Ask A Doctor If
  • you have rectal bleeding or fail to have bowl 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 at (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 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 

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

Do Not Use (Do not use)

if you cannot swallow without chewing.

Other Information (Other information)
  • store at room temperature
  • Protect from excessive humidity
Inactive Ingredients (Inactive ingredients)

acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow No. 10, FD&C yellow No. 6, 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# 68163-116-25

*Compare to the Active Ingredient in Dulcolax® Tablets

Bisacodyl Laxative

Bisacodyl, USP 5 mg/Stimulant Laxative

Gentle, Overnight relief constipation relief

25 Coated Tablets

*This product is not manufactured or distributed by Chattem Inc., the owner of the registered trademark Dulcolax® Tablets.

TAMPER EVIDENT: Do not use if any individual unit is broken or open.

IMPORTANT:Keep this carton for future reference on full labeling.

Manufactured by:

Raritan Pharmaceuticals

8 Joanna Court,

East Brunswick, NJ 08816

When Using This Product (When using this product)
  • it may cause stomach discomfort, faintness and cramps
  • do not chew or crush tablet(s)
  • 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 fail to have bowl 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 at (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

All Sections (JSON)