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

Description

Active ingredient                  (In each tablet)   Bisacodyl 5mg

Purpose

Stimulant Laxative


Medication Information

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

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.

Section 55106-9

Active ingredient                 

(In each tablet)

  Bisacodyl 5mg

Warnings

Do not use if you cannot swallow without chewing

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
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

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

Questions Or Comments?

1-888-287-1915


Structured Label Content

Indications and Usage (34067-9)

Uses

  • for relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 6 to 12 hours
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.

Section 55106-9 (55106-9)

Active ingredient                 

(In each tablet)

  Bisacodyl 5mg

Purpose

Stimulant Laxative

Warnings

Do not use if you cannot swallow without chewing

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
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

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

Questions Or Comments? (Questions or comments?)

1-888-287-1915


Advanced Ingredient Data


Raw Label Data

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