Hst 455b (555)

Hst 455b (555)
SPL v2
SPL
SPL Set ID d7146449-c43e-460a-9ae0-aa1966eaa3b6
Route
ORAL
Published
Effective Date 2026-01-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides (8.6 mg) Docusate (50 mg)
Inactive Ingredients
Microcrystalline Cellulose Croscarmellose Sodium Anhydrous Dibasic Calcium Phosphate Magnesium Stearate Polyethylene Glycol, Unspecified Hypromellose, Unspecified Fd&c Yellow No. 6 Titanium Dioxide Talc Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: PSD22 Shape: round Color: orange Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-11

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.

Warnings

Do not use for more than one 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 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

Package Label
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

Repackaged By: Preferred Pharmaceuticals Inc.

Inactive Ingredients

cellulose, croscarmellose sodium, dicalcium phosphate, FD&C yellow #6 lake, hypromellose, magnesium stearate, PEG, silica, talc, titanium dioxide.

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.

Purpose

Stool softener

Laxative

Warnings

Do not use for more than one 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 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

Package Label
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

Repackaged By: Preferred Pharmaceuticals Inc.

Inactive Ingredients (Inactive ingredients)

cellulose, croscarmellose sodium, dicalcium phosphate, FD&C yellow #6 lake, hypromellose, magnesium stearate, PEG, silica, talc, titanium dioxide.

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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