Right Remedies

Right Remedies
SPL v2
SPL
SPL Set ID 322beeab-cdff-3a31-e063-6294a90a0c52
Route
ORAL
Published
Effective Date 2025-04-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Deacetylbisacodyl (5 mg)
Inactive Ingredients
Acacia Calcium Carbonate Croscarmellose Sodium D&c Yellow No. 10 Aluminum Lake Anhydrous Dibasic Calcium Phosphate Fd&c Yellow No. 6 Aluminum Lake Gelatin, Unspecified Glyceryl Monostearate Hypromellose, Unspecified Ferric Oxide Red Magnesium Stearate Methacrylic Acid And Ethyl Acrylate Copolymer Microcrystalline Cellulose Polyethylene Glycol, Unspecified Silicon Dioxide Methylparaben Sodium Propylparaben Sodium Sodium Starch Glycolate Type A Starch, Corn Sucrose Talc Titanium Dioxide Triethyl Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-25

Description

Bisacodyl (USP) 5 mg

Purpose

Stimulant laxative


Medication Information

Purpose

Stimulant laxative

Description

Bisacodyl (USP) 5 mg

Use

for relief of occasional constipation and irregularity

this product generally produces bowel movement in 6 to12 hours

Section 42229-5

Compare to the active ingredient in Dulcolax ® Laxative Tablets*

Gentle, effective

overnight relief of

occasional constipation

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Sanofi-Aventis Deutschland GMBH, owner of the registered trademark Dulcolax® Laxative Tablets.

Distributed by: Strive Pharmaceuticals Inc.,

East Brunswick, NJ 08816

PRODUCT OF INDIA

Section 50565-1

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Warnings

Do not use

if you cannot swallow without chewing.

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

When using this product

it may cause stomach discomfort, faintness and cramps

do not chew or crush tablet(s)

do not use within 1 hour after taking an antacid or milk

Stop use and ask a doctor if

you have rectal bleeding or fail to have a 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

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

Packaging

Directions

do not take more than directed

take with a glass of water

adults and children 12 years of age and over 1 to 3 tablets in a single daily dose. It is recommended to start with the lowest dose (1 tablet) and increasing the next day as needed
children 6 to under 12 years of age 1 tablet in a single daily dose
children under 6 years ask a doctor

Drug Facts

Other Information

contains FD&C Yellow No. 6

store at room temperature between 20˚–25˚C (68˚–77˚F)

protect from light, heat and moisture

Inactive Ingredients

acacia gum, calcium carbonate, croscarmellose sodium, D&C Yellow No.10 aluminum lake, dibasic calcium phosphate, FD&C Yellow No. 6 aluminum lake, gelatin, glycerol monostearate, hypromellose, iron oxide red, magnesium stearate, methacrylic acid co-polymer type C, microcrystalline cellulose, polyethylene glycol, precipitated silica, silicon dioxide, sodium methylparaben, sodium propylparaben, sodium starch glycolate, starch, sucrose, talcum, titanium dioxide, triethyl citrate

Questions Or Comments?

1-888-577-8033 Monday - Friday 8am - 4pm EST

Active Ingredient (in Each Tablet)

Bisacodyl (USP) 5 mg


Structured Label Content

Use

for relief of occasional constipation and irregularity

this product generally produces bowel movement in 6 to12 hours

Section 42229-5 (42229-5)

Compare to the active ingredient in Dulcolax ® Laxative Tablets*

Gentle, effective

overnight relief of

occasional constipation

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Sanofi-Aventis Deutschland GMBH, owner of the registered trademark Dulcolax® Laxative Tablets.

Distributed by: Strive Pharmaceuticals Inc.,

East Brunswick, NJ 08816

PRODUCT OF INDIA

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.

Purpose

Stimulant laxative

Warnings

Do not use

if you cannot swallow without chewing.

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

When using this product

it may cause stomach discomfort, faintness and cramps

do not chew or crush tablet(s)

do not use within 1 hour after taking an antacid or milk

Stop use and ask a doctor if

you have rectal bleeding or fail to have a 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

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

Packaging

Directions

do not take more than directed

take with a glass of water

adults and children 12 years of age and over 1 to 3 tablets in a single daily dose. It is recommended to start with the lowest dose (1 tablet) and increasing the next day as needed
children 6 to under 12 years of age 1 tablet in a single daily dose
children under 6 years ask a doctor

Drug Facts

Other Information (Other information)

contains FD&C Yellow No. 6

store at room temperature between 20˚–25˚C (68˚–77˚F)

protect from light, heat and moisture

Inactive Ingredients (Inactive ingredients)

acacia gum, calcium carbonate, croscarmellose sodium, D&C Yellow No.10 aluminum lake, dibasic calcium phosphate, FD&C Yellow No. 6 aluminum lake, gelatin, glycerol monostearate, hypromellose, iron oxide red, magnesium stearate, methacrylic acid co-polymer type C, microcrystalline cellulose, polyethylene glycol, precipitated silica, silicon dioxide, sodium methylparaben, sodium propylparaben, sodium starch glycolate, starch, sucrose, talcum, titanium dioxide, triethyl citrate

Questions Or Comments? (Questions or comments?)

1-888-577-8033 Monday - Friday 8am - 4pm EST

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Bisacodyl (USP) 5 mg


Advanced Ingredient Data


Raw Label Data

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