Sennosides / Docusate Sodium

Sennosides / Docusate Sodium
SPL v1
SPL
SPL Set ID 1a21b07a-263c-41a4-ba0c-ad2dc5a295d7
Route
ORAL
Published
Effective Date 2025-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (50 mg) Sennosides (8.6 mg)
Inactive Ingredients
Starch, Corn Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate Fd&c Blue No. 1 Aluminum Lake Fd&c Red No. 40 Aluminum Lake Fd&c Yellow No. 6 Aluminum Lake Hypromellose, Unspecified Magnesium Stearate Maltodextrin Microcrystalline Cellulose Light Mineral Oil Polyethylene Glycol 400 Sodium Benzoate Sodium Lauryl Sulfate Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 49;0 Shape: round Color: red Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-12

Description

Active ingredients (in each tablet) Docusate sodium 50 mg Sennosides 8.6 mg


Medication Information

Description

Active ingredients (in each tablet) Docusate sodium 50 mg Sennosides 8.6 mg

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 12 hours
Section 42229-5

Keep this carton for complete product information

Tamper Evident:

Do not use if sealed blister units are broken or damaged.

Distributed by:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.majorpharmaceuticals.com

Overbagged with 10 tablets per bag, NDC 55154-0195-0

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Distributed By:

Cardinal Health

Dublin, OH 43017

L6083711-11025 / L6083711-21025

Rev. 02/24

M-29

Re-order No. 701390

Section 55105-1

Purposes

Stool softener

Stimulant laxative

Warnings

.

Directions
  • take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.

adults and children 12 years and over

take 2-4 tablets daily

children 6 to under 12 years of age

take 1-2 tablets daily

children 2 to under 6 years of age

take up to 1 tablet daily

children under 2 years

ask a doctor

Do Not Use
  • laxative products for longer than 1 week unless told to do so by a doctor
  • if you are presently taking mineral oil, unless told to do so by a doctor
Drug Facts

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Other Information
  • each tablet contains: calcium 5 mg
  • Store in a dry place at 15° – 30°C (59° – 86°F).
Inactive Ingredients

corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #6 lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium benzoate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide.

Questions Or Comments?

1-800-231-4670

Principal Display Panel

NDC 55154-0195-0

Sennosides/Docusate Sodium

8.6 mg/50 mg

Stool Softener/Stimulant Laxative

10 TABLETS

Stop Use and Ask A Doctor If

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over two weeks

Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 12 hours
Section 42229-5 (42229-5)

Keep this carton for complete product information

Tamper Evident:

Do not use if sealed blister units are broken or damaged.

Distributed by:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.majorpharmaceuticals.com

Overbagged with 10 tablets per bag, NDC 55154-0195-0

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Distributed By:

Cardinal Health

Dublin, OH 43017

L6083711-11025 / L6083711-21025

Rev. 02/24

M-29

Re-order No. 701390

Section 55105-1 (55105-1)

Purposes

Stool softener

Stimulant laxative

Warnings

.

Directions
  • take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.

adults and children 12 years and over

take 2-4 tablets daily

children 6 to under 12 years of age

take 1-2 tablets daily

children 2 to under 6 years of age

take up to 1 tablet daily

children under 2 years

ask a doctor

Do Not Use (Do not use)
  • laxative products for longer than 1 week unless told to do so by a doctor
  • if you are presently taking mineral oil, unless told to do so by a doctor
Drug Facts

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Other Information (Other information)
  • each tablet contains: calcium 5 mg
  • Store in a dry place at 15° – 30°C (59° – 86°F).
Inactive Ingredients

corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #6 lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium benzoate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide.

Questions Or Comments? (Questions or comments?)

1-800-231-4670

Principal Display Panel

NDC 55154-0195-0

Sennosides/Docusate Sodium

8.6 mg/50 mg

Stool Softener/Stimulant Laxative

10 TABLETS

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over two weeks

Advanced Ingredient Data


Raw Label Data

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