topcare 44-676a-womens laxative-delisted

topcare 44-676a-womens laxative-delisted
SPL v9
SPL
SPL Set ID f437550a-67ef-4576-80b9-b9af4cff4139
Route
oral
Published
Effective Date 2024-07-18
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 2019-05-01 Until 2026-03-31

Purpose

Stimulant laxative 

Description

Bisacodyl USP, 5 mg 


Medication Information

Active Ingredient

Bisacodyl USP, 5 mg 

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
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

Description

Bisacodyl USP, 5 mg 

Principal Display Panel

+TopCare®

health

NDC 36800-676-01

Women's Gentle

Laxative

BISACODYL USP 5 mg • STIMULANT LAXATIVE

Gentle, Dependable, Relief

from Constipation

30 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

50844     REV011967601

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007 ©TOPCO LNKA0521

QUESTIONS? 1-888-423-0139

[email protected]     www.topcarebrand.com

Visit here for more information: http://topbrnds.com/48ZZSE

QUALITY GUARANTEED

TopCare 44-676A
Do Not Use

if you cannot swallow without chewing. 

Questions Or Comments?

1-888-423-0139

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. 

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

Active Ingredient (Active ingredient (in each tablet))

Bisacodyl USP, 5 mg 

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
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

Principal Display Panel

+TopCare®

health

NDC 36800-676-01

Women's Gentle

Laxative

BISACODYL USP 5 mg • STIMULANT LAXATIVE

Gentle, Dependable, Relief

from Constipation

30 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

50844     REV011967601

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007 ©TOPCO LNKA0521

QUESTIONS? 1-888-423-0139

[email protected]     www.topcarebrand.com

Visit here for more information: http://topbrnds.com/48ZZSE

QUALITY GUARANTEED

TopCare 44-676A
Do Not Use (Do not use)

if you cannot swallow without chewing. 

Questions Or Comments? (Questions or comments?)

1-888-423-0139

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. 

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

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