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

Purpose

Stool softener Laxative

Description

Docusate Sodium 50 mg Sennosides 8.6 mg


Medication Information

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.

Active Ingredient

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
Purpose

Stool softener

Laxative

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

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.

Description

Docusate Sodium 50 mg Sennosides 8.6 mg

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Package Label


Structured Label Content

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.

Active Ingredient (Active ingredient (in each tablet))

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
Purpose

Stool softener

Laxative

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

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.

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.

Package Label


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)