Ldr441

Ldr441
SPL v5
SPL
SPL Set ID 97b83b7a-1a41-71e7-e053-2995a90ac640
Route
ORAL
Published
Effective Date 2013-02-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Deacetylbisacodyl (5 mg)
Inactive Ingredients
Ammonia Calcium Carbonate Acacia Carnauba Wax Starch, Corn D&c Yellow No. 10 Fd&c Yellow No. 6 Hypromelloses Ferrosoferric Oxide Lactose Monohydrate Magnesium Stearate Methylparaben Polydextrose Polyethylene Glycol, Unspecified Polyvinyl Acetate Phthalate Propylparaben Propylene Glycol Povidone Shellac Dimethicone Silicon Dioxide 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 2019-11-01

Description

Bisacodyl 5 mg

Purpose

Stimulant Laxative


Medication Information

Purpose

Stimulant Laxative

Description

Bisacodyl 5 mg

Uses
  • for relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 6 to 12 hour
Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Warnings

Do not use if you cannot swallow without chewing

Ask a doctor before use if you have

  • stomach pain, nausea, vomiting
  • noticed a sudden change in bowel habits that lasts more than 2 weeks

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 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

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

Directions

  • take with a glass of water
  • adults and children 12 years and older: take 1 to 3 tablets in a single daily dose
  • children 12 years and under: ask a doctor
Package Label

Other Information
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken
  • store at room temperature
  • avoid excessive humidity
Inactive Ingredients

Acacia, Ammonium Hydroxide, Calcium Carbonate, Corn Starch, D and C Yellow NO. 10 Lake, FD and C Yellow NO. 6 Lake, Hypromellose, Iron Oxide Black, Lactose, Magnesium Stearate, Methylparaben, PEG, Polydextrose, Polyvinyl Acetate Phthalate, Propylparaben, Propylene Glycol, Povidone, Shellac, Simethicone, Silica, Sodium Alginate, Sodium Benzoate, Sodium Bicarbonate, Stearic Acid, Sucrose, Talc, Titanium Dioxide, Triacetin, Triethyl Citrate, Wax

Active Ingredient (in Each Tablet)

Bisacodyl 5 mg


Structured Label Content

Uses
  • for relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 6 to 12 hour
Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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, vomiting
  • noticed a sudden change in bowel habits that lasts more than 2 weeks

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 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

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

Directions

  • take with a glass of water
  • adults and children 12 years and older: take 1 to 3 tablets in a single daily dose
  • children 12 years and under: ask a doctor
Package Label

Other Information (Other information)
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken
  • store at room temperature
  • avoid excessive humidity
Inactive Ingredients (Inactive ingredients)

Acacia, Ammonium Hydroxide, Calcium Carbonate, Corn Starch, D and C Yellow NO. 10 Lake, FD and C Yellow NO. 6 Lake, Hypromellose, Iron Oxide Black, Lactose, Magnesium Stearate, Methylparaben, PEG, Polydextrose, Polyvinyl Acetate Phthalate, Propylparaben, Propylene Glycol, Povidone, Shellac, Simethicone, Silica, Sodium Alginate, Sodium Benzoate, Sodium Bicarbonate, Stearic Acid, Sucrose, Talc, Titanium Dioxide, Triacetin, Triethyl Citrate, Wax

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

Bisacodyl 5 mg


Advanced Ingredient Data


Raw Label Data

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