Publix 44-676a-womens Laxative-delisted

Publix 44-676a-womens Laxative-delisted
SPL v5
SPL
SPL Set ID b4cd91af-ace1-477c-9e3a-89b027da0a56
Route
ORAL
Published
Effective Date 2024-08-27
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 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 Completed Since 2021-09-22 Until 2026-03-18

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
  • 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • avoid excessive humidity

  • see end flap for expiration date and lot number

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

Principal Display Panel

NDC 56062-676-01

WOMEN'S

laxative

BISACODYL USP, 5 mg

STIMULANT LAXATIVE

• Overnight relief

• Gentle, dependable, constipation relief

30 COMFORT

COATED TABLETS

ACTUAL SIZE

DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.,

3300 PUBLIX CORPORATE PARKWAY

LAKELAND, FL 33811

1-888-267-3037 publix.com

PUBLIX GURANTEE: COMPLETE

SATISFACTION OR YOUR MONEY BACK

PUBLIX

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR

SHOWS ANY SIGNS OF TAMPERING

50844     ORG011967601

Publix 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

  • you may have 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
  • 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • avoid excessive humidity

  • see end flap for expiration date and lot number

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

Principal Display Panel (Principal display panel)

NDC 56062-676-01

WOMEN'S

laxative

BISACODYL USP, 5 mg

STIMULANT LAXATIVE

• Overnight relief

• Gentle, dependable, constipation relief

30 COMFORT

COATED TABLETS

ACTUAL SIZE

DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.,

3300 PUBLIX CORPORATE PARKWAY

LAKELAND, FL 33811

1-888-267-3037 publix.com

PUBLIX GURANTEE: COMPLETE

SATISFACTION OR YOUR MONEY BACK

PUBLIX

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR

SHOWS ANY SIGNS OF TAMPERING

50844     ORG011967601

Publix 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

  • you may have 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)