Senna-s Tablet
FDA Label NDC 80513-105

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advanced Rx Llc for the product Senna-s (NDC 80513-105). 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 other, otc - purpose, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active ingredients (in each tablet)                    Purpose

Docusate sodium 50 mg.......................................Stool softner

Sennosides 8.6 mg................................................Laxative

Uses

  • relieves occasional constipation (irregularity)
  • generally causes bowel movement in 6-12 hours

Do Not Use

  • if you are now 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 You Have

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

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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - 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.

Directions

take preferably at bedtime or as directed by a doctor

age

starting dosage

maximum dosage

adults and children 12 years of age 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

½ 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 21 mg, sodium 3 mg. VERY LOW SODIUM
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive Ingredients

May contain:croscarmellose sodium, colloidal silicon dioxide, dicalcium phosphate, FD&C red,  D&C Yellow#10, FD&C Yellow#6, hypromellose, magnesium stearate, microcrystalline cellulose, stearic acid, titanium dioxide

Questions Or Comments?

Call 1-800-630-8895

Principal Display Panel

NDC 80513-105-25

*Compare to  Senokot-S ® active ingredients

SENNA-S

Docusate Sodium and Sennosides Tablets, 50 mg and 8.6 mg

Dual Action

Natural Vegetable Laxative + Stool Softener

250 Tablets

*This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot-S ®.

Principal Display Panel (Senna S)

Principal Display Panel (Senna S)

* Please review the disclaimer below.