Label: SENNA SYRUP- sennosides liquid
- NDC Code(s): 0121-4967-05, 0121-4967-40
- Packager: Pharmaceutical Associates, 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 September 1, 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 pharmacist before use if you have
- stomach pain
- noticed a sudden changed 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 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
- store at room temperature 20° to 25°C (68° to 77°F).
- a brown, natural flavored syrup supplied in the following oral dosage form:
NDC 0121-4967-05: 5 mL unit dose cup, in a tray of ten cups.
NDC 0121-4967-40: Case contains 40 unit dose cups of 5 mL (0121-4967-05) packaged in 4 trays of 10 unit dose cups each.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0121-4967 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 CITRIC ACID ACETATE (UNII: DSO12WL7AU) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SUCROSE (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0121-4967-40 4 in 1 CASE 03/22/2022 1 10 in 1 TRAY 1 NDC:0121-4967-05 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 03/22/2022 Labeler - Pharmaceutical Associates, Inc. (044940096) Registrant - Pharmaceutical Associates, Inc. (097630693) Establishment Name Address ID/FEI Business Operations Pharmaceutical Associates, Inc. 097630693 manufacture(0121-4967) , label(0121-4967)