Senna S

Senna S
SPL v6
SPL
SPL Set ID 9c87759f-3856-4f30-b5ea-4b37ed90f18c
Route
ORAL
Published
Effective Date 2019-01-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sennosides (8.6 mg) Docusate (50 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium D&c Yellow No. 10 Fd&c Yellow No. 6 Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Sodium Benzoate Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: S6 Shape: round Color: orange Size: 9 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-10-01

Description

SENNOSIDES AND DOCUSATE SODIUM- sennosides , docusate sodium tablet Marlex Pharmaceuticals, Inc. Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------- Senna S Drug Facts

Purpose

Stool softener Stimulant laxative


Medication Information

Purpose

Stool softener Stimulant laxative

Description

SENNOSIDES AND DOCUSATE SODIUM- sennosides , docusate sodium tablet Marlex Pharmaceuticals, Inc. Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------- Senna S Drug Facts

Uses
  • relieves occasional constipation (irregularity)

  • generally causes bowel movement in 6-12 hours
Section 42229-5

SENNOSIDES AND DOCUSATE SODIUM- sennosides , docusate sodium tablet Marlex Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Senna S

Drug Facts

Directions
  • take preferably at bedtime or as directed by a doctor

  • if you do not have a comfortable bowel movement by the second day, increase does by one tablet (do not exceed maximum dosage) or decrease does until you are comfortable
age starting dosage maximum dosage
adults and children 12 years of age and older 2 tablets once a day 4 tablets twice a day
children 6 to 12 years 1 tablet once a day 2 tablets twice a day
children 2 to 6 years 1/2 tablet once a day 1 tablet twice a day
children under 2 years ask a doctor ask a doctor
Do Not Use
  • this product if you are presently taking mineral oil, unless directed by a doctor

  • laxative products for longer than 1 week unless directed by a doctor
Other Information
  • each tablet contains:calcium 4mg, sodium 8mg

  • store at 20°C to 25°C (68°F to 77°F) excursions permitted between 15°30°C (59°-86°F)
Inactive Ingredients

Colloidal silicon dioxide, croscarmellose sodium, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, titanium dioxide

*Compare to the active ingredients in SENOKOT-S®

Principal Display Panel

NDC 10135-0669-01

Senna S

100 TABLET

Stop Use and Ask A Doctor

you have rectal bleeding or fail to have a bowel movement after use if 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.

Active Ingredient (in Each Tablet)

Docusate Sodium 50mg Sennosides 8.6 mg

Ask A Doctor Before Use If You Have
  • stomach pain

  • Nausea

  • Vomiting

  • a sudden change in bowel movements that persists over 2 weeks

Structured Label Content

Uses
  • relieves occasional constipation (irregularity)

  • generally causes bowel movement in 6-12 hours
Section 42229-5 (42229-5)

SENNOSIDES AND DOCUSATE SODIUM- sennosides , docusate sodium tablet Marlex Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Senna S

Drug Facts

Purpose

Stool softener Stimulant laxative

Directions
  • take preferably at bedtime or as directed by a doctor

  • if you do not have a comfortable bowel movement by the second day, increase does by one tablet (do not exceed maximum dosage) or decrease does until you are comfortable
age starting dosage maximum dosage
adults and children 12 years of age and older 2 tablets once a day 4 tablets twice a day
children 6 to 12 years 1 tablet once a day 2 tablets twice a day
children 2 to 6 years 1/2 tablet once a day 1 tablet twice a day
children under 2 years ask a doctor ask a doctor
Do Not Use (Do not use)
  • this product if you are presently taking mineral oil, unless directed by a doctor

  • laxative products for longer than 1 week unless directed by a doctor
Other Information (Other information)
  • each tablet contains:calcium 4mg, sodium 8mg

  • store at 20°C to 25°C (68°F to 77°F) excursions permitted between 15°30°C (59°-86°F)
Inactive Ingredients (Inactive ingredients)

Colloidal silicon dioxide, croscarmellose sodium, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, titanium dioxide

*Compare to the active ingredients in SENOKOT-S®

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 10135-0669-01

Senna S

100 TABLET

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

you have rectal bleeding or fail to have a bowel movement after use if 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.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Docusate Sodium 50mg Sennosides 8.6 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • stomach pain

  • Nausea

  • Vomiting

  • a sudden change in bowel movements that persists over 2 weeks

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)