65a1cce7-984f-490a-bd68-fea97733a72f

SPL v1
SPL
SPL Set ID 65a1cce7-984f-490a-bd68-fea97733a72f
Route
oral
Published
Effective Date 2025-06-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
docusate (50 mg) sennosides (8.6 mg)
Inactive Ingredients
polyethylene glycol 400 propylene glycol yellow wax povidone k30 silicon dioxide gelatin glycerin sorbitol solution sorbitan fd&c red no. 40 fd&c yellow no. 6 titanium dioxide water

Identifiers & Packaging

Pill Appearance
Imprint: SD17 Shape: oval Color: orange Size: 13 mm Score: 1
Marketing Status
otc monograph drug active Since 2025-06-24

Purpose

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

Description

Docusate Sodium 50 mg Sennosides 8.6 mg


Medication Information

Purpose

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

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

Directions

age

starting dosage

maximum dosage

adults & children 12 years of age and over

2 softgels once a day

4 softgels twice a day

children 6 to under 12 years

1 softgel once a day

2 softgels twice a day

children under 6 years

ask a doctor

ask a doctor

Other Information
  • Each softgel contains: Calcium 3 mg, Sodium 5 mg VERY LOW SODIUM
  • store at 25°C (77°F) excursions permitted between15°-30°C (59°-86°F)
Inactive Ingredients

Polyethylene Glycol 400, Propylene Glycol, Yellow Beeswax, Povidone (PVPK-30), Colloidal silicon dioxide (Aerosil), Gelatin, Glycerin, Sorbitol Sorbitan Solution, FD & C Red No.40, FD & C Yellow No.6, Titanium Dioxide, Purified Water.

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.

Questions Or Comments?

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

Active Ingredient (in Each Softgel)

Docusate Sodium 50 mg

Sennosides 8.6 mg


Structured Label Content

Purpose

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

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

Directions (DIRECTIONS)

age

starting dosage

maximum dosage

adults & children 12 years of age and over

2 softgels once a day

4 softgels twice a day

children 6 to under 12 years

1 softgel once a day

2 softgels twice a day

children under 6 years

ask a doctor

ask a doctor

Other Information (OTHER INFORMATION)
  • Each softgel contains: Calcium 3 mg, Sodium 5 mg VERY LOW SODIUM
  • store at 25°C (77°F) excursions permitted between15°-30°C (59°-86°F)
Inactive Ingredients (INACTIVE INGREDIENTS)

Polyethylene Glycol 400, Propylene Glycol, Yellow Beeswax, Povidone (PVPK-30), Colloidal silicon dioxide (Aerosil), Gelatin, Glycerin, Sorbitol Sorbitan Solution, FD & C Red No.40, FD & C Yellow No.6, Titanium Dioxide, Purified Water.

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.
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.

Questions Or Comments? (QUESTIONS OR COMMENTS?)

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

Active Ingredient (in Each Softgel) (Active Ingredient (in each softgel))

Docusate Sodium 50 mg

Sennosides 8.6 mg


Advanced Ingredient Data


Raw Label Data

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