Gs 303b (304)

Gs 303b (304)
SPL v2
SPL
SPL Set ID 17cdef7b-71bf-b4a6-e063-6294a90a5b74
Route
ORAL
Published
Effective Date 2015-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides (8.6 mg) Docusate (50 mg)
Inactive Ingredients
Polyethylene Glycol, Unspecified Hypromelloses Fd&c Blue No. 2 Titanium Dioxide Magnesium Stearate Cellulose, Microcrystalline Croscarmellose Sodium Calcium Phosphate, Dibasic, Dihydrate Fd&c Red No. 40 Silicon Dioxide Talc

Identifiers & Packaging

Pill Appearance
Imprint: PSD21 Shape: round Color: red Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-01

Description

Docusate Sodium 50 mg Sennosides 8.6 mg

Purpose

Stool softener Stimulant laxative


Medication Information

Purpose

Stool softener

Stimulant laxative

Description

Docusate Sodium 50 mg Sennosides 8.6 mg

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6-12 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

  • laxative products for longer than 1 week unless directed by a doctor
  • if you are presently taking mineral oil, unless told to do so by a doctor

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • 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
  • Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses
adults and children 12 years and over take 2-4 tablets daily
children 6 to under 12 years of age take 1- 2 tablets daily
children 2 to under 6 years of age take up to 1 tablet daily
children under 12 years of age ask a doctor

Package Label

Other Information
  • each tablet contains: calcium 20 mg, sodium 3 mg, VERY LOW SODIUM
  • store at 20-25 C (68-77 F); excursions permitted between 15-30 C (59-86 F)

Inactive Ingredients

cellulose, croscarmellose sodium, dicalcium phosphate, FD&C blue #2 lake, FD&C red #40 lake, hypromellose, magnesium stearate, PEG, silica, talc, titanium dioxide.

Questions Or Comments?

1-800-540-3765

Active Ingredient (in Each Tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg


Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6-12 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

Stimulant laxative

Warnings

Do not use

  • laxative products for longer than 1 week unless directed by a doctor
  • if you are presently taking mineral oil, unless told to do so by a doctor

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • 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
  • Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses
adults and children 12 years and over take 2-4 tablets daily
children 6 to under 12 years of age take 1- 2 tablets daily
children 2 to under 6 years of age take up to 1 tablet daily
children under 12 years of age ask a doctor

Package Label

Other Information (Other information)
  • each tablet contains: calcium 20 mg, sodium 3 mg, VERY LOW SODIUM
  • store at 20-25 C (68-77 F); excursions permitted between 15-30 C (59-86 F)

Inactive Ingredients (Inactive ingredients)

cellulose, croscarmellose sodium, dicalcium phosphate, FD&C blue #2 lake, FD&C red #40 lake, hypromellose, magnesium stearate, PEG, silica, talc, titanium dioxide.

Questions Or Comments? (Questions or comments?)

1-800-540-3765

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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