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 (26.4 mg/15 mL)
Unit Dose Cup

Drug Facts

Active Ingredient (in each 15 mL = 3 teaspoonful) Sennosides 26.4 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.

Directions:
• Shake well before use • Do not exceed recommended dose

Age

Dose

Adults and children 12 years of age and over15 – 30 mL up to 2 times a day
Children under 12 years of ageAsk a doctor

3 teaspoon = 15 mL

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: 48433-222-15 Senna Syrup 26.4 mg/15 mL Unit Dose Cup
NDC: 48433-222-40 Box of 40 Unit-Dose Cups, each unit-dose cup delivers 15 mL

For Oral Use Only.
For Institutional Use Only.
This Package Is Not Child Resistant.

Packaged By:
Safecor Health, LLC
4060 Business Park Drive
Columbus, OH 43204

05/2023 PN5737

———Principal Display Panel Box Label———

SAFECOR HEALTH
                                                                              NDC: 48433-222-40
Senna Syrup                                                         Qty: 40
26.4 mg Sennosides per 15 mL                           Lot: 23A0081

Contains 40 (15 mL) Unit Dose Cups                       Exp: 2025-07-31
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: 233000041

Pkg By: Safecor Health, LLC Columbus, OH 43204           Exp: 2025-07-31
     Questions or Comments: Call 1-800-447-1006           Lot: 23A0081

———Principal Display Panel Unit Dose Cup Label———

Delivers 15 mL

NDC 48433-222-15

Senna Syrup

Each 15 mL Contains:

Sennosides 26.4 mg

SHAKE WELL

348433222157

Pkg By: Safecor Health, LLC

Columbus, OH 43204

PN5923.A

Box Label
Unit Dose Cup Label
SENNA SYRUP 
sennosides liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48433-222(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:48433-222-4040 in 1 BOX08/07/2023
1NDC:48433-222-1515 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 finalpart33408/07/2023
Labeler - Safecor Health, LLC (828269675)
Establishment
NameAddressID/FEIBusiness Operations
Safecor Health, LLC828269675repack(48433-222)
Establishment
NameAddressID/FEIBusiness Operations
Llorens Pharmaceutical International Division, Inc.037342305manufacture(48433-222)

Revised: 8/2023
Document Id: 2b10fac7-8e9b-40fd-a004-1160886d35e3
Set id: 60847955-3f52-4474-811f-2ab39d9689bc
Version: 2
Effective Time: 20230813
 
Safecor Health, LLC