crw 455b

crw 455b
SPL v1
SPL
SPL Set ID 4742182e-fdf9-44fe-e063-6394a90adfcc
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 2025-12-01

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

Other Information
  • each tablet contains: calcium 20 mg, sodium 3 mg Very low sodium.
  • store at 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-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.

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

Other Information (Other information)
  • each tablet contains: calcium 20 mg, sodium 3 mg Very low sodium.
  • store at 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-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.

Package Label

Questions Or Comments? (Questions or comments?)

1-800-540-3765


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)