Hpc 455b

Hpc 455b
SPL v4
SPL
SPL Set ID fd653118-18c7-463e-e053-6294a90a2c7e
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
Croscarmellose Sodium Calcium Phosphate, Dibasic, Anhydrous Magnesium Stearate Polyethylene Glycol, Unspecified Hypromelloses Fd&c Yellow No. 6 Titanium Dioxide Talc Silicon Dioxide Cellulose, Microcrystalline

Identifiers & Packaging

Pill Appearance
Imprint: PSD22 Shape: round Color: orange Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2022-12-01 Until 2026-06-30
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 (800-222-1222).

Warnings

Do not use

  • if you are now taking mineral oil, unless directed 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 or vomiting
  • noticed a sudden change in bowel habits that lasts over two 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 ask a doctor

Package Label

Other Information
  • each tablet contains: calcium 20 mg, sodium 3 mg
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
  • store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F).

Inactive Ingredients

cellulose, croscarmellose sodium, dicalcium phosphate, FD&C yellow #6 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)
  • 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 (800-222-1222).

Purpose

Stool softener

Laxative

Warnings

Do not use

  • if you are now taking mineral oil, unless directed 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 or vomiting
  • noticed a sudden change in bowel habits that lasts over two 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 ask a doctor

Package Label

Other Information (Other information)
  • each tablet contains: calcium 20 mg, sodium 3 mg
  • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
  • store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F).

Inactive Ingredients (Inactive ingredients)

cellulose, croscarmellose sodium, dicalcium phosphate, FD&C yellow #6 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

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:08:03.653461 · Updated: 2026-03-14T23:12:12.345571