SPL v2
SPL
SPL Set ID 9e999e4a-2f72-4a2b-a41b-bdd68bf5a350
Route
ORAL
Published
Effective Date 2024-07-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (50 mg) Sennosides (8.6 mg)
Inactive Ingredients
Croscarmellose Sodium Silicon Dioxide Anhydrous Dibasic Calcium Phosphate Fd&c Red No. 3 Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Maltodextrin Polyethylene Glycol, Unspecified Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: none Shape: round Color: red Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-17

Description

Docusate Sodium 50 mg Sennosides 8.6 mg

Purpose

Docusate Sodium............... Stool softener Sennosides........................Laxative


Medication Information

Purpose

Docusate Sodium............... Stool softener

Sennosides........................Laxative

Description

Docusate Sodium 50 mg Sennosides 8.6 mg

Uses:
  • Relieves occasional constipation (irregularity).
  • 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 (1-800-222-1222) right away.

Section 50566-9

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.
Section 50569-3

Ask a doctor before use if you have: 

  • Stomach pain
  • nausea
  • vomiting
  • Noticed a sudden change in bowel habits that continues over a period of 2 weeks.
Section 51945-4

Section 53414-9
  • If pregnant or breast-feeding, ask a health professional before use.
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.

Directions

Take preferably at bedtime or as directed by a doctor.

age

starting dosage

maximum dosage

adults & children 12 years of age and over

2 tablets once a day

4 tablets twice a day

children 6 to under 12 years

1 tablet once a day

2 tablets twice a day

children 2 to under 6 years

1 /2 tablet once a day

1 tablet twice a day

children under 2 years

ask a doctor

ask a doctor

Other Information
  • Each tablet contains: Calcium 19.92 mg, Sodium 5.61 mg VERY LOW SODIUM
  • store at 25°C (77°F) excursions permitted between15°-30°C (59°-86°F)
Inactive Ingredients

Croscarmellose Sodium, Colloidal Silicon Dioxide, Dicalcium Phosphate, F D & C Red, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Maltodextrin, Polyethylene Glycol, Stearic acid Powder, Titanium Dioxide.

Questions Or Comments?

Call 1 (718) 337-8733 or visit: [email protected]

Active Ingredients (in Each Tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg


Structured Label Content

Uses:
  • Relieves occasional constipation (irregularity).
  • 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 (1-800-222-1222) right away.

Section 50566-9 (50566-9)

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.
Section 50569-3 (50569-3)

Ask a doctor before use if you have: 

  • Stomach pain
  • nausea
  • vomiting
  • Noticed a sudden change in bowel habits that continues over a period of 2 weeks.
Section 51945-4 (51945-4)

Section 53414-9 (53414-9)
  • If pregnant or breast-feeding, ask a health professional before use.
Purpose

Docusate Sodium............... Stool softener

Sennosides........................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.

Directions (DIRECTIONS)

Take preferably at bedtime or as directed by a doctor.

age

starting dosage

maximum dosage

adults & children 12 years of age and over

2 tablets once a day

4 tablets twice a day

children 6 to under 12 years

1 tablet once a day

2 tablets twice a day

children 2 to under 6 years

1 /2 tablet once a day

1 tablet twice a day

children under 2 years

ask a doctor

ask a doctor

Other Information (OTHER INFORMATION)
  • Each tablet contains: Calcium 19.92 mg, Sodium 5.61 mg VERY LOW SODIUM
  • store at 25°C (77°F) excursions permitted between15°-30°C (59°-86°F)
Inactive Ingredients (INACTIVE INGREDIENTS)

Croscarmellose Sodium, Colloidal Silicon Dioxide, Dicalcium Phosphate, F D & C Red, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Maltodextrin, Polyethylene Glycol, Stearic acid Powder, Titanium Dioxide.

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call 1 (718) 337-8733 or visit: [email protected]

Active Ingredients (in Each Tablet) (Active Ingredients (in each tablet))

Docusate Sodium 50 mg

Sennosides 8.6 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)