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 5 mL = 1 teaspoonful)
Sennosides 8.8 mg

PURPOSE

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

1 teaspoonful = 5 mL
Directions: Shake well before use Do not exceed recommended dose
Age	Starting Dose	Maximum Dosage
Adults and children 12 years of age and over	2 to 3 teaspoonfuls (10 mL to 15 mL) once a day preferably at bedtime; increase as needed or as recommended by a doctor	3 teaspoonfuls (15 mL) in the morning and 3 teaspoonfuls (15 mL) at bedtime
Children under 12 years of age	Ask a doctor	Ask a doctor

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: 48433-219-05 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

———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

INGREDIENTS AND APPEARANCE

SENNA SYRUP 
sennosides liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48433-219(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)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48433-219-40	40 in 1 BOX	03/01/2020
1	NDC: 48433-219-05	5 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	03/01/2020

Labeler - Safecor Health, LLC (828269675)