gentle laxative

gentle laxative
SPL v5
SPL
SPL Set ID 9b466e37-4c7d-4237-8a9d-2994113707f4
Route
oral
Published
Effective Date 2022-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
deacetylbisacodyl (5 mg)
Inactive Ingredients
acacia anhydrous lactose carnauba wax silicon dioxide starch, corn fd&c yellow no. 6 methacrylic acid magnesium stearate cellulose, microcrystalline polyvinyl acetate phthalate shellac sodium starch glycolate type a stearic acid talc titanium dioxide triacetin

Identifiers & Packaging

Pill Appearance
Imprint: F Shape: round Color: orange Size: 5 mm Score: 1
Marketing Status
otc monograph drug active Since 2022-12-27 Until 2027-03-31

Purpose

Stimulant Laxative

Description

Active ingredient                  (In each tablet)   Bisacodyl 5mg


Medication Information

Warnings

Do not use if you cannot swallow without chewing

Active Ingredient

Active ingredient                 

(In each tablet)

  Bisacodyl 5mg

Indications and Usage

Uses

  • for relief of occasional constipation and 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
  • each tablet contains: magnesium 5 mg
  • store at 25°C (77°F) , excursions permitted between 15-30°C (59-86°F)
  • protect from excessive humidity
Inactive Ingredients

acacia, carnauba wax, collodial silicon dioxide, corn starch, FD&C yellow #6, lactose anhydrous, magnesium stearate, methacrylic acid,

microcrystalline cellulose, polyvinyl acetate, shellac, sodium starch glycoale, stearic acid, talc, titanium dioxide, triacetin

Description

Active ingredient                  (In each tablet)   Bisacodyl 5mg

Section 42229-5

Distributed by:

Walmart Inc.

Bentonville, AR 72716



Product of India

*This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., distributor of Dulcolax® Laxative.

Section 50565-1

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.

Section 50566-9

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
Section 50567-7

When using this product

  • do not chew or crush tablet(s)
  • it may cause stomach discomfort, faintness and cramps
  • do not use within 1 hour after taking an antacid or milk
Section 50569-3

Ask a doctor before use if you have

  • stomach pain, nausea or vomiting
  • noticed a sudden change in bowel habits that lasts more than 2 weeks
Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Display Panel

Compare to Dulcolax® Laxative active ingredient*



GENTLE LAXATIVE

BISACODYL 5 mg

  • Overnight Relief
  • Gentle, dependable constipation relief
  • Relief in 6-12 hours



8 TABLETS

ENTERIC COATED

Questions Or Comments?

1-888-287-1915


Structured Label Content

Warnings

Do not use if you cannot swallow without chewing

Active Ingredient (55106-9)

Active ingredient                 

(In each tablet)

  Bisacodyl 5mg

Indications and Usage (34067-9)

Uses

  • for relief of occasional constipation and 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)
  • each tablet contains: magnesium 5 mg
  • store at 25°C (77°F) , excursions permitted between 15-30°C (59-86°F)
  • protect from excessive humidity
Inactive Ingredients (Inactive ingredients)

acacia, carnauba wax, collodial silicon dioxide, corn starch, FD&C yellow #6, lactose anhydrous, magnesium stearate, methacrylic acid,

microcrystalline cellulose, polyvinyl acetate, shellac, sodium starch glycoale, stearic acid, talc, titanium dioxide, triacetin

Section 42229-5 (42229-5)

Distributed by:

Walmart Inc.

Bentonville, AR 72716



Product of India

*This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., distributor of Dulcolax® Laxative.

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

When using this product

  • do not chew or crush tablet(s)
  • it may cause stomach discomfort, faintness and cramps
  • do not use within 1 hour after taking an antacid or milk
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • stomach pain, nausea or vomiting
  • noticed a sudden change in bowel habits that lasts more than 2 weeks
Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Display Panel (DISPLAY PANEL)

Compare to Dulcolax® Laxative active ingredient*



GENTLE LAXATIVE

BISACODYL 5 mg

  • Overnight Relief
  • Gentle, dependable constipation relief
  • Relief in 6-12 hours



8 TABLETS

ENTERIC COATED

Questions Or Comments? (Questions or comments?)

1-888-287-1915


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)