Otc - Active Ingredient
Senna Syrup
Active ingredient
(in each 5 mL teaspoonful)
Sennosides - 8.8 mg
Senna Syrup Liquid
FDA Label NDC 57237-301
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rising Pharma Holdings, Inc. for the product Senna Syrup (NDC 57237-301). 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, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Laxative
Indications & Usage
Uses
- relieves occasional constipation (irregularity)
- generally causes bowel movement 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 before use if you have
- stomach pain, nausea or vomitting
- noticed a change in bowel habits that lasts over two weeks.
Stope 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.
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 immediately.
Dosage & Administration
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 teaspoonfuls in the morning and 3 teaspoonfuls at bedtime |
| Under 12 years of age | ask a doctor | ask a doctor |
Storage And Handling
Other information
- store at room temperature 15° to 25° C (59° to 77° F)
TAMPER-EVIDENT: Do not use if foil seal over bottle opening is torn, broken, or missing.
Inactive Ingredient
Inactive ingredients:artificial and natural chocolate flavor, methylparaben, propylene glycol, propylparaben, purified water, sucrose.
Otc - Questions
Questions or comments?
Call 1-844-474-7464
Package Label.Principal Display Panel
Sennalabel01 (Senna Label01)
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