Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Safecor Health, LLC
Safecor Health, LLC
828269675
Llorens Pharmaceutical International Division, Inc.
Safecor Health, LLC
037342305
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Senna Syrup
Product Details
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
PACKAGE LABEL.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 CupsExp: 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 43204Exp: 2025-07-31
Questions or Comments: Call 1-800-447-1006Lot: 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
INDICATIONS & USAGE SECTION
Use: • relieves occasional constipation (irregularity), generally causes bowel movement in 6-12 hours.
DOSAGE & ADMINISTRATION SECTION
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
WARNINGS SECTION
WARNINGS: Do not use • laxative products for a period longer than 1 week unless directed by a doctor
STORAGE AND HANDLING SECTION
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.
OTC - ACTIVE INGREDIENT SECTION
Drug Facts
**Active Ingredient (in each 15 mL = 3 teaspoonful)**Sennosides 26.4 mg
OTC - PURPOSE SECTION
Purpose
Laxative
OTC - ASK DOCTOR SECTION
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
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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.
OTC - STOP USE SECTION
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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast feeding, ask a health care professional before use.
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
INACTIVE INGREDIENT SECTION
Inactive ingredients: Artificial and natural chocolate flavor, methylparaben, propylparaben, propylene glycol, sucrose and purified water.