SENNA- sennosides a and b syrup 
Rij Pharmaceutical Corporation

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.

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Senna Syrup

Drug Facts

Active Ingredient (in each teaspoonful)

Sennosides 8.8 mg

Purpose

Laxative

Uses

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
  • vomiting
  • noticed a sudden change in bowel movements that continues over a period of 2 weeks

Stop use and ask a doctor if you have rectal bleeding or fail to have bowel movement after use of laxative. These may indicate a serious condition.

If pregnant or breast-feeding, ask a professional before use.

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

AgeStarting DoseMaximum dosage
adults and children 12 years and older2 - 3 teaspoons once a day preferable at bedtime; increase as needed or as recommended by a doctor3 teaspoons in the morning and 3 teaspoons at bedtime
Under 12 years of ageask a doctorask a doctor

Other information

TAMPER EVIDENT: Do not use this product if breakaway band on cap is broken or missing.

Inactive ingredients

flavors, parabens, propylene glycol, sucrose, and water.

RIJ Pharmaceuticals Corporation
40 Commercial Avenue
Middletown, NY 10941

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

NDC 53807-556-08

Senna Syrup
Senna Syrup
Natural Vegetable Laxative

8 fl. oz. (237 mL)

Principal Display Panel - 237 mL Bottle Label
SENNA 
sennosides a and b syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53807-556
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sennosides A and B (UNII: 1B5FPI42EN) (Sennosides A and B - UNII:1B5FPI42EN) Sennosides A and B8.8 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Methylparaben (UNII: A2I8C7HI9T)  
propylene glycol (UNII: 6DC9Q167V3)  
propylparaben (UNII: Z8IX2SC1OH)  
water (UNII: 059QF0KO0R)  
cocoa (UNII: D9108TZ9KG)  
sucrose (UNII: C151H8M554)  
Product Characteristics
ColorBROWNScore    
ShapeSize
FlavorCHOCOLATEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53807-556-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/08/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33411/08/2016
Labeler - Rij Pharmaceutical Corporation (144679156)
Establishment
NameAddressID/FEIBusiness Operations
Rij Pharmaceutical Corporation144679156manufacture(53807-556)

Revised: 4/2018
Document Id: 50888fd7-aa39-4423-81a4-e087e0bf1779
Set id: 7633b1ef-c369-4a14-b425-e742f7c3b320
Version: 2
Effective Time: 20180430
 
Rij Pharmaceutical Corporation