14r - Bisacodayl-tcl

14r - Bisacodayl-tcl
SPL v7
SPL
SPL Set ID e0a9f8d9-660b-431c-8043-6d8ec81f98e5
Route
ORAL
Published
Effective Date 2018-12-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Deacetylbisacodyl (5 mg)
Inactive Ingredients
Acacia Calcium Sulfate Anhydrous Anhydrous Lactose Carnauba Wax Silicon Dioxide Starch, Corn D&c Yellow No. 10 Fd&c Yellow No. 6 Gelatin Ferrosoferric Oxide Ferric Oxide Yellow Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol 400 Polyvinyl Acetate Phthalate Povidone Shellac Sodium Starch Glycolate Type A Corn Stearic Acid Sucrose Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: TCL003 Shape: round Color: orange Size: 5 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-04-01

Description

In each tablet: Bisacodyl 5mg


Medication Information

Warnings and Precautions

Warning: Do not use if you cannot swallow without chewing.

Ask a doctor before use if you have: stomach pain, nausea or vomiting; A sudden change in bowel habits that lasts more than two weeks.

When using this product: Do not chew or crush tablet(s); Do not use within 1 hour after taking an antacid or milk; Do not use this product if you have stomach discomfort, faintness or cramps.

Indications and Usage

Uses:

  • relieves occasional constipation and irregularity
  • this product generally produces a bowel movement in 6 to 12 hours

Dosage and Administration
  • 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
Description

In each tablet: Bisacodyl 5mg

Section 50565-1

Keep out of Reach of Children:  In case of overdose, get medical help or contact a Poison Control Center right away.

Section 51727-6

Acadia, Anhydrous Calcium Sulfate, Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Corn Starch, D&C Yellow #10 Aluminum Lake, FD&C yellow #6 aluminum lake, Gelatin, Iron Oxide, Iron Oxide Black, Iron Oxide Yellow(Iron Oxide Ochre), Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol (PEG) 400, Polyvinyl Acetate Phthalates, Povidone, Shellac, Sodium Starch Glycolate, Stearic Acid, Sugar, Talc, Titanium Dioxide

Section 55105-1

Stimulant Laxative

Section 55106-9

In each tablet: Bisacodyl 5mg

1000 Ct 14r

25 Count Blister

100 Count Label 14r


Structured Label Content

Indications and Usage (34067-9)

Uses:

  • relieves occasional constipation and irregularity
  • this product generally produces a bowel movement in 6 to 12 hours

Dosage and Administration (34068-7)
  • 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
Warnings and Precautions (34071-1)

Warning: Do not use if you cannot swallow without chewing.

Ask a doctor before use if you have: stomach pain, nausea or vomiting; A sudden change in bowel habits that lasts more than two weeks.

When using this product: Do not chew or crush tablet(s); Do not use within 1 hour after taking an antacid or milk; Do not use this product if you have stomach discomfort, faintness or cramps.

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.

Section 51727-6 (51727-6)

Acadia, Anhydrous Calcium Sulfate, Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Corn Starch, D&C Yellow #10 Aluminum Lake, FD&C yellow #6 aluminum lake, Gelatin, Iron Oxide, Iron Oxide Black, Iron Oxide Yellow(Iron Oxide Ochre), Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol (PEG) 400, Polyvinyl Acetate Phthalates, Povidone, Shellac, Sodium Starch Glycolate, Stearic Acid, Sugar, Talc, Titanium Dioxide

Section 55105-1 (55105-1)

Stimulant Laxative

Section 55106-9 (55106-9)

In each tablet: Bisacodyl 5mg

1000 Ct 14r (1000 CT 14R)

25 Count Blister (25 COUNT BLISTER)

100 Count Label 14r (100 count label 14R)


Advanced Ingredient Data


Raw Label Data

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