Hst 455b (555)

SPL v6

SPL

SPL Set ID 8a0882ed-f623-2359-e053-2995a90a6f98

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

Cellulose, Microcrystalline Croscarmellose Sodium Calcium Phosphate, Dibasic, Anhydrous Magnesium Stearate Polyethylene Glycol, Unspecified Hypromelloses 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 2019-05-01

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

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
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 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.

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

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
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 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.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Docusate Sodium 50 mg

Sennosides 8.6 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "relieves occasional constipation (irregularity) this product generally produces a bowel movement in 6 to 12 hours", "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 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 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", "Other information": "each tablet contains: calcium 20 mg, sodium 3 mg 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.", "Active ingredient (in each tablet)": "Docusate Sodium 50 mg Sennosides 8.6 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:34.291941 · Updated: 2026-03-14T23:05:25.370894