Active Ingredient (Per Teaspoonful - 5 Ml) Purpose
Sennosides 8.8 mg Laxative
Senna Liquid
FDA Label NDC 0904-7528
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Senna (NDC 0904-7528). 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 (per teaspoonful - 5 ml) purpose, uses, warnings, ask a doctor or pharmacist before use if you have, stop use and ask a doctor if, if pregnant or breastfeeding,, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
- relieves occasional constipation (irregularity)
- generally causes bowel movement in 6 to 12 hours
Warnings
Do not use
• laxative products for longer than 1 week unless directed by a doctor.
Ask A Doctor Or Pharmacist Before Use If You Have
• stomach pain • nausea • vomiting
• noticed a change 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 movement after use of laxative. These may indicate a serious condition.
If Pregnant Or Breastfeeding,
ask a health professional before use.
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.
Directions
• shake well before using • Do not exceed recommended dose
| Age | Starting Dose | Maximum Dose |
| adults and children 12 years and older | 2 to 3 teaspoonfuls once a day preferably at bedtime; increase as needed or as recommended by a doctor | 3 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 0904-7528-41: 5 mL unit dose cup, in a tray of ten cups.
NDC 0904-7528-94: Case contains 40 unit dose cups of 5 mL (0904-7528-41) packaged in 4 trays of 10 unit dose cups each.
Inactive Ingredients:
citric acid, glycerin, methylparaben, potassium sorbate, propylparaben, purified water, and sucrose.
Questions Or Comments?
Call 1-800-845-8210.
Distributed By:
R10/24
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
Principal Display Panel
Major®
NDC 09045-7528-41
Senna Syrup
8.8 mg Sennosides/5 mL
Senna Syrup (Lid)
* Please review the disclaimer below.
