Senna Tablet
FDA Label NDC 81005-101

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aarkish Pharmaceuticals Nj Inc. for the product Senna (NDC 81005-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient(s), purpose, use(s), do not use, warnings, ask a doctor before use if, stop use and ask doctor if, pregnancy/breastfeeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient(s)

→ Purpose

→ Use(s)

→ Do Not Use

→ Warnings

→ Ask A Doctor Before Use If

→ Stop Use And Ask Doctor If

→ Pregnancy/breastfeeding

→ Keep Out Of Reach Of Children

→ Directions

→ Storage

→ Inactive Ingredients

→ Other

→ Principal Display Panel

Active Ingredient(S)

Sennosides 8.6 mg

Purpose

Laxative

Use(S)

relieve occasional constipation (irregularity)
this product generally produces a bowel movement in 6 to 12 hours

Do Not Use

Laxative products for longer than 1 week unless directed by a doctor

Warnings

Ask A Doctor Before Use If

stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that continues over a period of 2 weeks

Stop Use And Ask Doctor If

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

Pregnancy/Breastfeeding

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.

Directions

take preferably at bedtime or as directed by a doctor
do not exceed maximum dosage

age	starting dose	maximum dosage
adults and children 12 years of age or older	2 tablets once a day	4 tablets twice a day
children 6 to under 12 years	1 tablet once a day	2 tablets twice a day
children 2 to under 6 years	1/2 tablet once a day	1 tablet twice a day
children under 2 years	ask a doctor	ask a doctor

Storage

each tablet contains: calcium 4 mg, sodium 3 mg
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose

Other

Senna Tablets

Sennosides 8.6 mg

Aarkish Pharmaceuticals NJ 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.