gs 303b (304)

gs 303b (304)
SPL v2
SPL
SPL Set ID 261a88d6-87d2-7544-e063-6294a90a2e94
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 2025-03-01

Purpose

Stool softener Stimulant laxative

Description

Docusate Sodium 50 mg Sennosides 8.6 mg


Medication Information

Warnings

Do not use

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

Active Ingredient

Docusate Sodium 50 mg

Sennosides 8.6 mg

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

Stool softener

Stimulant laxative

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 under 12 years ask a doctor

Other Information
  • each tablet contains: calcium 20 mg, sodium 3 mg
  • store at controlled room temperature
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
  • product of India

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.

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

Questions Or Comments?

1-800-540-3765


Structured Label Content

Warnings

Do not use

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

Active Ingredient (Active ingredient (in each tablet))

Docusate Sodium 50 mg

Sennosides 8.6 mg

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

Stool softener

Stimulant laxative

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 under 12 years ask a doctor

Other Information (Other information)
  • each tablet contains: calcium 20 mg, sodium 3 mg
  • store at controlled room temperature
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
  • product of India

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.

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

Questions Or Comments? (Questions or comments?)

1-800-540-3765


Advanced Ingredient Data


Raw Label Data

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