SENNA- sennosides a and b syrup 
LLC Federal Solutions

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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Drug Facts

Active Ingredient (in each teaspoonful)
Sennosides 8.8 mg

Purpose
Laxative

Uses
relieves occasional constipation (irregularity), generally produces bowel movement in 6-12 hours

Warnings

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

Do not use laxative products for longer than 1 week unless directed by a doctor

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

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 this and all drugs out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions
Take preferably at bedtime or as directed by a doctor. Shake Well Before Using.

agestarting dosemaximum dosage
adults and children 12 years and older2 - 3 teaspoons once a day3 teaspoons twice a day
children 6 to under 12 years1 - 1 1/2 teaspoons once a day1 1/2 teaspoons twice a day
children 2 to under 6 years1/2 - 3/4 teaspoon once a day3/4 teaspoon twice a day
children under 2 yearsask a doctorask a doctor

Other information

  • avoid excessive heat
  • store at room temperature 15°- 30°C (59°- 86°F)

Inactive ingredients
cocoa distillate flavor, natural chocolate flavor, methylparaben, propylene glycol, propylparaben, purified water, sucrose

Questions? Call 1-855-333-6337
To Report suspected adverse reactions, contact the FDA at 1-800-FDA-1088

Repackaged by:
Safecor Health, LLC
317 New Boston St.
Woburn, MA 01801
Distributed by: LLC Federal Solutions
14 NE 1st Ave.
Miami, FL 33132



———PRINCIPAL DISPLAY PANEL———
NDC: 24451-289-05
SENNA SYRUP
(STANDARDIZED EXTRACT OF SENNA FRUIT)
DELIVERS 5 mL
CONTAINING:
SENNOSIDES 8.8 mg
ALCOHOL FREE
NATURAL CHOCOLATE FLAVOR
SHAKE WELL
Exp: 00/00/00 Lot # 00000

Rpk By: Safecor Health LLC
Woburn, MA 01801
Dist. By: LLC Federal Solutions
Miami, FL 33132
product label

SENNA 
sennosides a and b syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24451-289(NDC:0904-6289)
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
COCOA (UNII: D9108TZ9KG)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SUCROSE (UNII: C151H8M554)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorCHOCOLATE (NATURAL CHOCOLATE FLAVOR) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24451-289-05100 in 1 BOX08/12/201312/31/2019
15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2NDC:24451-289-10100 in 1 BOX08/12/201312/31/2019
210 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33408/12/201312/31/2019
Labeler - LLC Federal Solutions (965036895)
Establishment
NameAddressID/FEIBusiness Operations
Safecor Health, LLC828269675repack(24451-289)

Revised: 1/2020
Document Id: 2ae22434-2f6a-418b-a26f-9ce99b38788d
Set id: cd5c6f7c-a658-47ef-9626-eb35cd3f10b6
Version: 2
Effective Time: 20200107
 
LLC Federal Solutions