Label: SENNA SYRUP- sennosides liquid
- NDC Code(s): 54859-808-08
- Packager: Llorens Pharmaceutical International Division, Inc.
- 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.
Updated July 10, 2022
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
Do not use
- laxative products for longer than 1 week unless directed by a doctor
Ask a doctor or pharmacis before use if you have
- stomach pain
- noticed a sudden changed in bowel movement that continues over a period of 2 weeks
Stope use and ask a doctor if
you have rectal bleeding or failure to have a bowel movemebt after use of laxative. They may indicate a serious condition.
- KEEP OUT OF REACH OF CHILDREN
DOSAGE & ADMINISTRATION
- shake well before use
- Do not exceed recommended dose
Age Starting Dose Maximum dosage Adults and children 12 years and older 2-3 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
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54859-808 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) SUCRALOSE (UNII: 96K6UQ3ZD4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54859-808-08 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 05/01/2019 Labeler - Llorens Pharmaceutical International Division, Inc. (037342305) Registrant - Llorens Pharmaceutical International Division, Inc. (037342305)