Senna Syrup
FDA Label NDC 66424-562
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sda Laboratories, Inc. for the product Senna Syrup (NDC 66424-562). 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 drug facts, active ingredient (in each 5 ml), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each 5 Ml)
Sennosides 8.8 mg
Purpose
Laxative
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
• 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
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.
Directions
• shake well before use
• take preferably at bedtime or as directed by a doctor
| Age | Starting Dose | Maximum dosage |
adults and children 12 years and older | 2-3 teaspoonfuls once a day | 3 teaspoonfuls twice 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 | 1/2-3/4 teaspoon once a day | 3/4 teaspoon twice a day |
| under 2 years of age | ask a doctor | ask a doctor |
Other Information
• Store at room temperature 15°-30°C (59°-86°F)
TAMPER EVIDENT: Do not use this product if breakaway band on cap is broken or missing
Inactive Ingredient:
flavors, methyl paraben, propyl paraben, sucrose and water.
Other
Natural Vegetable Laxative
For Gentle, Relief of Constipation
* Compare to Active ingredient of Senokot®
* This product is not manufactured or distributed by the owner of the registered trademark Senokot®
Distributed By: SDA Laboratories Inc.
280 Railroad Ave. Greenwich, CT. 06830
* Please review the disclaimer below.
