SENNA SYRUP- sennosides liquid 
Safecor Health, LLC

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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SAFECOR HEALTH

Senna Syrup (8.8 mg/5 mL)
Unit Dose Cup

Drug Facts

Active Ingredient (in each 5 mL = 1 teaspoonful)
Sennosides 8.8 mg

Purpose
Laxative

Use: • relieves occasional constipation (irregularity), generally causes bowel movement in 6-12 hours.

WARNINGS: Do not use • laxative products for a period 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 movement that continues over a period of 2 weeks

Stop use and ask a doctor if you have • rectal bleeding • no bowel movement after use of laxative

These could be signs of a serious condition.

If pregnant or breast feeding, ask a health care 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 immediately. In case of eye contact, flush with water.

1 teaspoonful = 5 mL
Directions:
  • Shake well before use
  • Do not exceed recommended dose
AgeStarting DoseMaximum Dosage
Adults and children 12 years of age and over2 to 3 teaspoonfuls (10 mL to 15 mL) once a day preferably at bedtime; increase as needed or as recommended by a doctor3 teaspoonfuls (15 mL) in the morning and 3 teaspoonfuls (15 mL) at bedtime
Children under 12 years of age Ask a doctorAsk a doctor

Other information: Store at room temperature 15°C to 25°C (59°F to 77°F). Excursions between 26°C to 30°C (78°F to 86°F) are allowed. Protect from excessive heat. For more info call 1- 800-447-1006.

Inactive ingredients: Artificial and natural chocolate flavor, methylparaben, propylparaben, propylene glycol, sucrose and purified water.

NDC: 48433-219-05 Senna Syrup 8.8 mg/5 mL Unit Dose Cup

Mfd. in the U.S.A.
Distributed by: Safecor Health, LLC
4060 Business Park Drive, Columbus, OH 43204                                                               Rev: 02/2020 PN5497

———Principal Display Panel———

SAFECOR HEALTH
                                                                              NDC: 48433-219-40
Senna Syrup                                                         Qty: 40
8.8 mg Sennosides per 5 mL                                 Lot: 20A0020

Contains 40 (5 mL) Unit Dose Cups                      Exp: 210203
See monograph for complete drug information.
Store at room temperature 15°C to 25°C (59°F to 77°F);
excursions between 26°C to 30°C (78°F to 86°F) are allowed.
Protect from excessive heat.
This package design is not child resistant. For institutional use only.
Shake well before use.
                                                                                     GTIN: 00348433219409
                                                                                     SN: 200600019

Pkg By: Safecor Health, LLC Columbus, OH 43204   Exp: 210203
     Questions or Comments: Call 1-800-447-1006       Lot: 20A0020

Box Label
Unit Dose Cup Label
SENNA SYRUP 
sennosides liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48433-219(NDC:54859-808)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES8.8 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SUCROSE (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48433-219-4040 in 1 BOX03/01/2020
1NDC:48433-219-055 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 finalpart33403/01/2020
Labeler - Safecor Health, LLC (828269675)
Establishment
NameAddressID/FEIBusiness Operations
Safecor Health, LLC828269675repack(48433-219)
Establishment
NameAddressID/FEIBusiness Operations
Llorens Pharmaceutical International Division, Inc.037342305manufacture(48433-219)

Revised: 8/2023
Document Id: 3fab5a34-d4b8-4f6a-ac20-b0aa147b5c8d
Set id: e1dca0d6-6e6e-4ba2-a7b8-009aeb00ef63
Version: 3
Effective Time: 20230807
 
Safecor Health, LLC