Active Ingredient
Active ingredient (in each 5 ml) purpose
Sennosides 8.8 mg …………………………................Laxative
Senna Syrup
FDA Label NDC 17856-8237
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Atlantic Biologicals Corp. for the product Senna (NDC 17856-8237). 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, uses, directions, dosage & administration, warnings, other information, inactive ingredients, keep out of reach of children section, 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
Directions
shake well before use
take preferably at bedtime or as directed by a doctor
Dosage & Administration
Age Starting Dose Maximum Dose
adults and children 12 years 2 - 3 teaspoonfuls 3 teaspoonfuls twice a day
and older once a day
6 years to under 12 years of age 1 - 1½ teaspoonfuls once a day 1½ teaspoonfuls twice a day
2 to under 6 years of age ½ - ¾ teaspoon once a day ¾ teaspoon once a day
under 2 years of age consult a doctor consult a doctor
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
• notice a sudden 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 breast-feeding, ask a health
professional before use
Other Information
- Avoid accessive heat. Store at room temperature 15°-30°C (59°-86°F)
Inactive Ingredients
Mythylparaben, Propylene Glycol, Propylparaben, Purified Water, Sucrose
Keep Out Of Reach Of Children Section
In case of accidental overdose, get medical help or contact a Poison Control Center immediately
Questions?
To Report Adverse Drug Event Call 1(877) 225-6999
DISTRIBUTED BY:
ATLANTIC BIOLOGICALS CORP.
20101 N.E 16TH PLACE
MIAMI, FL 33179
Principal Panel
Image 1 (Cuplabel17856 8237)
Image 2 (17856 8237 01)
Image 3 (17856 8237 02)
Image 4 (17856 8237 03)
Image 5 (17856 8237 04)
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