Senna Tablet, Film Coated
FDA Label NDC 11822-0298

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Senna (NDC 11822-0298). 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 (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient (in Each Tablet)

→ Purpose

→ Uses

→ Do Not Use

→ Ask A Doctor Before Use If You Have

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ If Pregnant Or Breast-feeding,

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel

Active Ingredient (In Each Tablet)

Sennosides USP, 8.6 mg

Purpose

Stimulant laxative

Uses

relieves occasional constipation (irregularity)
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.

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

When Using This Product

do not exceed recommended dosage.

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.

Directions

take preferably at bedtime or as directed by a doctor

age	starting dosage	maximum dosage
adults and children 12 years and over	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

Other Information

each tablet contains: calcium 30 mg, sodium 1 mg Very Low Sodium
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
protect from moisture
see end flap for expiration date and lot number

Inactive Ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, silicon dioxide