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
Purpose

Stool softener Laxative

Description

Docusate Sodium 50 mg Sennosides 8.6 mg

Medication Information

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.

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 ask a doctor

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.

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 (800-222-1222).

Package Label

Questions Or Comments?

1-800-540-3765

Structured Label Content

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.

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 ask a doctor

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.

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).

Package Label

Questions Or Comments? (Questions or Comments?)

1-800-540-3765

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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