Heb 44-676a Gentle

Heb 44-676a Gentle
SPL v3
SPL
SPL Set ID 0fcc30a9-6daa-4b95-ae75-58059fb7a68e
Route
ORAL
Published
Effective Date 2025-09-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Deacetylbisacodyl (5 mg)
Inactive Ingredients
Silicon Dioxide Starch, Corn Fd&c Red No. 40 Aluminum Lake Hypromellose, Unspecified Anhydrous Lactose Magnesium Stearate Methacrylic Acid Microcrystalline Cellulose Polydextrose Polyethylene Glycol, Unspecified Shellac Dimethicone Water Sodium Bicarbonate Sodium Lauryl Sulfate Stearic Acid Talc Titanium Dioxide Triacetin Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Imprint: B Shape: round Color: pink Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-10

Description

Bisacodyl USP, 5 mg

Purpose

Stimulant laxative 


Medication Information

Purpose

Stimulant laxative 

Description

Bisacodyl USP, 5 mg

Uses
  • for relief of occasional constipation (irregularity)
  • this product generally produces bowel movement in 6 to 12 hours 
Directions
  • do not take more than directed
  • take with a glass of water
adults and children 12 years and over take 1 to 3 tablets in a single daily dose
children 6 to under 12 years take 1 tablet in a single daily dose
children under 6 years ask a doctor
Do Not Use

if you cannot swallow without chewing.

Other Information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 
  • avoid excessive humidity

Inactive Ingredients

carmine, colloidal silicon dioxide, corn starch, FD&C red #40 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

Questions Or Comments?

1-800-426-9391 

Principal Display Panel

H-E-B®

NDC 37808-680-11

Gentle

Laxative

Bisacodyl USP, 5 mg

Stimulant Laxative

Gentle

Overnight Relief

60 ENTERIC

COATED TABLETS

actual

size

TAMPER EVIDENT: DO NOT

USE IF PACKAGE IS OPENED

OR IF BLISTER UNIT IS

TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

MADE WITH PRIDE AND CARE FOR

H-E-B®, SAN ANTONIO, TX 78204

50844    REV0923C67611

100%

GUARANTEE

promise

HEB 44-676A

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 fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. 
  • you need to use a laxative for more than 1 week

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. 

Active Ingredient (in Each Tablet)

Bisacodyl USP, 5 mg

Ask A Doctor Before Use If You Have
  • a sudden change in bowel habits that lasts more than 2 weeks

  • stomach pain, nausea or vomiting


Structured Label Content

Uses
  • for relief of occasional constipation (irregularity)
  • this product generally produces bowel movement in 6 to 12 hours 
Purpose

Stimulant laxative 

Directions
  • do not take more than directed
  • take with a glass of water
adults and children 12 years and over take 1 to 3 tablets in a single daily dose
children 6 to under 12 years take 1 tablet in a single daily dose
children under 6 years ask a doctor
Do Not Use (Do not use)

if you cannot swallow without chewing.

Other Information (Other information)
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 
  • avoid excessive humidity

Inactive Ingredients (Inactive ingredients)

carmine, colloidal silicon dioxide, corn starch, FD&C red #40 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

Questions Or Comments? (Questions or comments?)

1-800-426-9391 

Principal Display Panel

H-E-B®

NDC 37808-680-11

Gentle

Laxative

Bisacodyl USP, 5 mg

Stimulant Laxative

Gentle

Overnight Relief

60 ENTERIC

COATED TABLETS

actual

size

TAMPER EVIDENT: DO NOT

USE IF PACKAGE IS OPENED

OR IF BLISTER UNIT IS

TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

MADE WITH PRIDE AND CARE FOR

H-E-B®, SAN ANTONIO, TX 78204

50844    REV0923C67611

100%

GUARANTEE

promise

HEB 44-676A

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 fail to have a bowel movement after use of a laxative. These could be signs of a serious condition. 
  • you need to use a laxative for more than 1 week

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

ask a health professional before use. 

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. 

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)
  • a sudden change in bowel habits that lasts more than 2 weeks

  • stomach pain, nausea or vomiting


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)