Label: SENNA SYRUP- sennosides liquid
- NDC Code(s): 57237-310-05, 57237-310-54
- Packager: Rising Health, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 23, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
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 vomiting
- noticed a change in bowel habits that lasts over two 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.
- PREGNANCY
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
- shake well before use
- do not exceed recommended dose
Age Starting Dose Maximum Dose Adults and children over 12 years of age 10 to 15 mL once a day at bedtime, increase as needed or as directed by a doctor 15 mL in the morning and 15 mL at bedtime Children under 12 years of age Ask a doctor Ask a doctor - Other information
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SENNA SYRUP
sennosides liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57237-310 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES 8.8 mg in 5 mL Inactive Ingredients Ingredient Name Strength METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SUCROSE (UNII: C151H8M554) Product Characteristics Color Score Shape Size Flavor CHOCOLATE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57237-310-54 40 in 1 BOX 05/23/2023 1 NDC:57237-310-05 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 05/23/2023 Labeler - Rising Health, LLC (080500961)