Senna Liquid
FDA Label NDC 0121-4967

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pai Holdings, Llc Dba Pai Pharma for the product Senna (NDC 0121-4967). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, pregnancy, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient (per teaspoonful - 5 mL)

Sennosides - 8.8 mg

Otc - Purpose

Purpose

Laxative

Indications & Usage

Uses

  • relieves occasional constipation (irregularity)
  • generally causes bowel movment in 6 to 12 hours

Warnings

Warnings

Do not use

  • laxative products for longer than 1 week unless directed by a doctor

    • Ask a doctor or pharmacis before use if you have

    • stomach pain
    • nausea
    • vomiting
    • noticed a sudden changed in bowel movement that continues over a period of 2 weeks

      • Stop use and ask a doctor if

      you have rectal bleeding or failure to have a bowel movemebt after use of laxative. They may indicate a serious condition.

Pregnancy

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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Dosage & Administration

  • shake well before use
  • Do not exceed recommended dose
    • AgeStarting Dose Maximum dosage
     Adults and children 12 years and older 2-3 teaspoonfuls once a day preferably at bedtime; increase as needed or as recommended by a doctor3 teaspoons in the morning and 3 teaspoons at bedtime
    Under 12 years of age ask a doctor ask a doctor

    Other information

    • store at room temperature 20° to 25°C (68° to 77°F).
    • a brown, natural flavored syrup supplied in the following oral dosage form:

      • NDC 0121-4967-05: 5 mL unit dose cup, in a tray of ten cups.
      NDC 0121-4967-40: Case contains 40 unit dose cups of 5 mL (0121-4967-05) packaged in 4 trays of 10 unit dose cups each.

Inactive Ingredient

Inactive ingredients: citric acid, glycerin, methylparaben, potassium sorbate, propylparaben, purified water, and sucrose.

Otc - Questions

Questions or comments? 1-800-845-8210

Other

Distributed By:

Pharmaceutical Associates, Inc.

Greenville, SC 29605

Package Label.Principal Display Panel

Delivers 5 mL
NDC 0121-4967-05

Senna Syrup

8.8 mg Sennosides/5 mL

Natural Vegetable Laxative

Package Not Child-Resistant

Pharmacutical Associates, Inc.
Greenville, SC 29605

SEE DRUG FACTS

Image Description (Senna 05)

Image Description (Senna 05)

* Please review the disclaimer below.