sennosides

sennosides
SPL v14
SPL
SPL Set ID 5ca287a3-c4f6-402d-978e-cd1328bdbc47
Route
oral
Published
Effective Date 2021-01-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
sennosides (8.6 mg)
Inactive Ingredients
silicon dioxide croscarmellose sodium hypromelloses magnesium stearate cellulose, microcrystalline stearic acid

Identifiers & Packaging

Pill Appearance
Imprint: S5 Shape: round Color: brown Size: 9 mm Score: 1
Marketing Status
otc monograph drug active Since 2018-10-01

Purpose

Laxative

Description

SENNOSIDES 8.6mg 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. ---------- Drug Facts


Medication Information

Active Ingredient

Sennosides 8.6 mg

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

Laxative

Directions
  • take preferably at bedtime or as directed by a doctor
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 under 12 years of age 1 tablet once a day 2 tablets twice a day
children 2 to under 6 years of age 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 4 mg , Sodium 3mg

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

Colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose.

*Compare to Senokot®

Product color may vary slightly due to nature of ingredients.

*Marlex Pharmaceuticals, Inc. is not affiliated with the owner of the registered trademark Senokot®.

Description

SENNOSIDES 8.6mg 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. ---------- Drug Facts

Principal Display Panel

NDC 10135-0314-01



Sennosides



8.6 mg



100 TABLETS

Section 42229-5

SENNOSIDES 8.6mg 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.

----------

Drug Facts

Do Not Use
  • laxative products for longer than 1 week unless directed by a doctor
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.

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 continues over a period of 2 weeks

Structured Label Content

Active Ingredient (Active ingredient (in each tablet))

Sennosides 8.6 mg

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

Laxative

Directions
  • take preferably at bedtime or as directed by a doctor
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 under 12 years of age 1 tablet once a day 2 tablets twice a day
children 2 to under 6 years of age 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 4 mg , Sodium 3mg

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

Colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose.

*Compare to Senokot®

Product color may vary slightly due to nature of ingredients.

*Marlex Pharmaceuticals, Inc. is not affiliated with the owner of the registered trademark Senokot®.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 10135-0314-01



Sennosides



8.6 mg



100 TABLETS

Section 42229-5 (42229-5)

SENNOSIDES 8.6mg 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.

----------

Drug Facts

Do Not Use (Do not use)
  • laxative products for longer than 1 week unless directed by a doctor
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 may indicate 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 continues over a period of 2 weeks

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)