Equaline 44-607

Equaline 44-607
SPL v16
SPL
SPL Set ID 1daeccb6-b8ab-43dc-a8fd-07ffc1fc1138
Route
ORAL
Published
Effective Date 2025-07-22
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 Red No. 27 Aluminum Lake Fd&c Blue No. 2 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: pink Size: 6 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-04-01

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
  • do not take more than directed
  • 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 25°C (77°F); 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 red #27 aluminum lake, FD&C blue #2 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?

1-855-423-2630

Principal Display Panel

EQUALINE®

compare to

Dulcolax Pink®

active ingredient*

NDC 41163-607-56

gentle

laxative

bisacodyl USP 5 mg

(stimulant laxative)

• gentle, dependable

  constipation relief

• enteric coated

25 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

100% Quality

GUARANTEED

DISTRIBUTED BY UNFI

PROVIDENCE, RI 02908 USA

855-423-2630

*This product is not manufactured or distributed by A. Nattermann & Cie. GmbH, owner of the

registered trademark Dulcolax Pink®.

50844    REV0823E60756

Equaline 44-607
When Using This Product
  • do not chew or crush tablet(s)
  • do not use within 1 hour after taking an antacid or milk
  • it may cause 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
  • stomach pain, nausea or vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks

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
  • do not take more than directed
  • 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 25°C (77°F); 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 red #27 aluminum lake, FD&C blue #2 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?)

1-855-423-2630

Principal Display Panel

EQUALINE®

compare to

Dulcolax Pink®

active ingredient*

NDC 41163-607-56

gentle

laxative

bisacodyl USP 5 mg

(stimulant laxative)

• gentle, dependable

  constipation relief

• enteric coated

25 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

100% Quality

GUARANTEED

DISTRIBUTED BY UNFI

PROVIDENCE, RI 02908 USA

855-423-2630

*This product is not manufactured or distributed by A. Nattermann & Cie. GmbH, owner of the

registered trademark Dulcolax Pink®.

50844    REV0823E60756

Equaline 44-607
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
  • it may cause 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)
  • stomach pain, nausea or vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)