Label: SENNA- sennosides liquid
- NDC Code(s): 0121-4967-05, 0121-4967-40
- Packager: PAI Holdings, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 5, 2024
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- 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 or pharmacist before use if you have
- stomach pain
- nausea
- vomiting
- 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.
- PREGNANCY
- 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 Other information
- 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
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SENNA
sennosides liquidProduct 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 Drug 505G(a)(3) 03/22/2022 Labeler - PAI Holdings, LLC (044940096) Establishment Name Address ID/FEI Business Operations PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma 097630693 label(0121-4967) , manufacture(0121-4967)
