Gc 455t (458)

Gc 455t (458)
SPL v6
SPL
SPL Set ID 616a896a-d238-7f7c-e053-2a91aa0a0f5b
Route
ORAL
Published
Effective Date 2013-03-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides (8.6 mg) Docusate (50 mg)
Inactive Ingredients
Cellulose, Microcrystalline Croscarmellose Sodium Calcium Phosphate, Dibasic, Anhydrous Magnesium Silicate Magnesium Stearate Mineral Oil Polyethylene Glycol, Unspecified Hypromelloses Fd&c Yellow No. 5 Fd&c Yellow No. 6 Sodium Benzoate Sodium Lauryl Sulfate Starch, Corn Stearic Acid Titanium Dioxide Triacetin Carnauba Wax D&c Yellow No. 10 Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: TCL081 Shape: round Color: orange Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2000-01-01 Until 2025-09-30

Description

Docusate Sodium 50 mg Sennosides 8.6 mg

Purpose

Stool softener Laxative


Medication Information

Purpose

Stool softener

Laxative

Description

Docusate Sodium 50 mg Sennosides 8.6 mg

Uses
  • relieves occasional constipation (irregularity)
  • this product generally produces a bowel movement in 6 to 12 hours
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 for more than 1 week unless directed by a doctor

Ask a doctor before use if you

  • have abdominal pain, nausea or vomiting
  • are taking mineral oil
  • have noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if you have rectal bleeding

or fail to have a bowel movement after use of a laxative.

These may indicate a serious condition.

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

Directions

• do not exceed 8 tablets in 24 hours

Age

Starting Dose

Maximum Dose

adults and children 12 years of age and older

2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor

4 tablets in the morning and 4 tablets at bedtime

children under 12 years

ask a doctor

Package Label

Other Information
  • each tablet contains: calcium 20 mg, sodium 6 mg
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
  • store at room temperature

Inactive Ingredients

cellulose, croscarmellose sodium, dicalcium phosphate, FD&C yellow #6, hypromellose, magnesium stearate, PEG, sodium benzoate, stearic acid, titanium dioxide. May also contain D&C yellow #10, FD&C yellow #5 (tartrazine), magnesium silicate, mineral oil, silica, sodium lauryl sulfate, starch, triacetin, wax.

Active Ingredient (in Each Tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg


Structured Label Content

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

Stool softener

Laxative

Warnings

Do not use for more than 1 week unless directed by a doctor

Ask a doctor before use if you

  • have abdominal pain, nausea or vomiting
  • are taking mineral oil
  • have noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if you have rectal bleeding

or fail to have a bowel movement after use of a laxative.

These may indicate a serious condition.

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

Directions

• do not exceed 8 tablets in 24 hours

Age

Starting Dose

Maximum Dose

adults and children 12 years of age and older

2 tablets once a day preferably at bedtime; increase as needed, or as directed by a doctor

4 tablets in the morning and 4 tablets at bedtime

children under 12 years

ask a doctor

Package Label

Other Information (Other information)
  • each tablet contains: calcium 20 mg, sodium 6 mg
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
  • store at room temperature

Inactive Ingredients (Inactive ingredients)

cellulose, croscarmellose sodium, dicalcium phosphate, FD&C yellow #6, hypromellose, magnesium stearate, PEG, sodium benzoate, stearic acid, titanium dioxide. May also contain D&C yellow #10, FD&C yellow #5 (tartrazine), magnesium silicate, mineral oil, silica, sodium lauryl sulfate, starch, triacetin, wax.

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

Docusate Sodium 50 mg

Sennosides 8.6 mg


Advanced Ingredient Data


Raw Label Data

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