Senna-s
FDA Label NDC 17714-124

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advance Pharmaceutical Inc. for the product Senna-s (NDC 17714-124). 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, active ingredient, 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Senna Tablets- 8.6 mg 

Docusate Sodium- 50 mg

Purpose

Senna Tablets- 8.6 mg ..........Laxative

Docusate Sodium- 50 mg........Stool softner

Uses

  • relieves occasional constipation (irregularity)
  • generally produces 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 lasts over 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

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

Other Information

  • each tablet contains: calcium 21 mg
  • each tablet contains: sodium 3 mg VERY LOW SODIUM
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • read all product information before using
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive Ingredients

carnuba wax, croscarmellose sodium, colloidal silicon dioxide, dicalcium phosphate, D&C Yellow # 10, FD&C Yellow # 6, hypromellose, microcrystalline cellulose, magnesium stearate, polyethylene glycol, stearic acid, titanium dioxide

Questions Or Comments?

call 631-981-4600, 8.30 am-4.30 pm ET, Monday - Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Principal Display Panel

NDC- 17714-124-10

Senna and Docusate Sodium Tablets, 8.6 mg and 50 mg

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