Quality Plus 44-327

Quality Plus 44-327
SPL v15
SPL
SPL Set ID c4ff36f2-6cdc-4d8a-a268-2919745047db
Route
ORAL
Published
Effective Date 2025-08-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Deacetylbisacodyl (5 mg)
Inactive Ingredients
Acacia Ammonia Calcium Carbonate Carnauba Wax Silicon Dioxide Starch, Corn D&c Yellow No. 10 Aluminum Lake Fd&c Yellow No. 6 Aluminum Lake Hypromellose, Unspecified Ferrosoferric Oxide Anhydrous Lactose Magnesium Stearate Methylparaben Polydextrose Polyethylene Glycol, Unspecified Polyvinyl Acetate Phthalate Povidone, Unspecified Propylene Glycol Propylparaben Shellac Dimethicone Water Sodium Alginate Sodium Benzoate Sodium Bicarbonate Stearic Acid Sucrose Talc Titanium Dioxide Triacetin Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Imprint: 5 Shape: round Color: orange Size: 6 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2002-03-25

Description

Bisacodyl USP, 5 mg

Purpose

Stimulant laxative


Medication Information

Purpose

Stimulant laxative

Description

Bisacodyl USP, 5 mg

Uses
  • for relief of occasional constipation and 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 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
  • avoid excessive humidity
  • see end flap for expiration date and lot number
Inactive Ingredients

acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black, lactose anhydrous, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac glaze, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

Questions Or Comments?

1-800-426-9391

Principal Display Panel

QUALITY

+PLUS

NDC 50844-327-15

*Compare to active ingredient in

Dulcolax® Laxative Tablets

GENTLE

LAXATIVE

Bisacodyl USP, 5 mg

STIMULANT LAXATIVE

Gentle, dependable constipation relief

50 Tablets

COMFORT COATED

ACTUAL SIZE

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR IF BLISTER UNIT

IS TORN, BROKEN OR SHOWS ANY SIGNS

OF TAMPERING

*This product is not manufactured or distributed

by Sanofi-Aventis Deutschland GMBH, owner of

the registered trademark Dulcolax® Laxative

Tablets.           50844        REV0119B32715

Distributed by

LNK INTERNATIONAL, INC.

60 Arkay Drive

Hauppauge, NY 11788

USA

Quality Plus 44-327
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 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


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 25ºC (77ºF); 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)

acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black, lactose anhydrous, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac glaze, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

QUALITY

+PLUS

NDC 50844-327-15

*Compare to active ingredient in

Dulcolax® Laxative Tablets

GENTLE

LAXATIVE

Bisacodyl USP, 5 mg

STIMULANT LAXATIVE

Gentle, dependable constipation relief

50 Tablets

COMFORT COATED

ACTUAL SIZE

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR IF BLISTER UNIT

IS TORN, BROKEN OR SHOWS ANY SIGNS

OF TAMPERING

*This product is not manufactured or distributed

by Sanofi-Aventis Deutschland GMBH, owner of

the registered trademark Dulcolax® Laxative

Tablets.           50844        REV0119B32715

Distributed by

LNK INTERNATIONAL, INC.

60 Arkay Drive

Hauppauge, NY 11788

USA

Quality Plus 44-327
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)