Pva 455b (555)

Pva 455b (555)
SPL v5
SPL
SPL Set ID d205915d-9f73-e0d7-e053-2995a90a0ee6
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 2020-12-01 Until 2025-10-31

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

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.

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

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)