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

Warnings

.

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

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.

Description

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

Principal Display Panel

NDC 55154-0195-0

Sennosides/Docusate Sodium

8.6 mg/50 mg

Stool Softener/Stimulant Laxative

10 TABLETS

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

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

Questions Or Comments?

1-800-231-4670

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

Warnings

.

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

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.

Principal Display Panel

NDC 55154-0195-0

Sennosides/Docusate Sodium

8.6 mg/50 mg

Stool Softener/Stimulant Laxative

10 TABLETS

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

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

Questions Or Comments? (Questions or comments?)

1-800-231-4670

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

All Sections (JSON)