Senna-s Tablet, Film Coated
FDA Label NDC 81005-102

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-s (NDC 81005-102). 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), warnings, stop use and ask doctor if, pregnancy/breastfeeding, do not use, ask a doctor before use if, 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)

→ Warnings

→ Stop Use And Ask Doctor If

→ Pregnancy/breastfeeding

→ Do Not Use

→ Ask A Doctor Before Use If

→ Keep Out Of Reach Of Children

→ Directions

→ Storage

→ Inactive Ingredient Section

→ Other

→ Principal Display Panel

Active Ingredient(S)

Docusate sodium 50 mg
Sennosides 8.6 mg

Purpose

Stool softener
Laxative

Use(S)

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

Warnings

See below for warnings

Stop Use And Ask Doctor If

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

Pregnancy/Breastfeeding

ask a health professional before 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

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

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 8 mg
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive Ingredient Section

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

Other

Senna-S

Docusate sodium 50 mg

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.