SENNA SYRUP- sennosides liquid

Senna Syrup by

Drug Labeling and Warnings

Senna Syrup by is a Otc medication manufactured, distributed, or labeled by Safecor Health, LLC, Llorens Pharmaceutical International Division, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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

Purpose

Laxative

INDICATIONS & USAGE

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

WARNINGS

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

ASK 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

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.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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.

DOSAGE & ADMINISTRATION

Directions:
Shake well before use Do not exceed recommended dose

• Age:

  Dose

• Adults and children 12 years of age and over: 15 – 30 mL up to 2 times a day
• Children under 12 years of age: Ask a doctor

3 teaspoon = 15 mL

STORAGE AND HANDLING

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 INGREDIENT

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

SPL UNCLASSIFIED SECTION

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

———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

INGREDIENTS AND APPEARANCE

SENNA SYRUP 
sennosides liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48433-222(NDC:54859-808)
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
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48433-222-40	40 in 1 BOX	08/07/2023
1	NDC: 48433-222-15	15 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 not final	part334	08/07/2023

Labeler - Safecor Health, LLC (828269675)

Establishment
Name	Address	ID/FEI	Business Operations
Safecor Health, LLC		828269675	repack(48433-222)

Establishment
Name	Address	ID/FEI	Business Operations
Llorens Pharmaceutical International Division, Inc.		037342305	manufacture(48433-222)