Senna by LLC Federal Solutions / Safecor Health, LLC

Senna by

Drug Labeling and Warnings

Senna by is a Otc medication manufactured, distributed, or labeled by LLC Federal Solutions, Safecor Health, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SENNA- sennosides a and b syrup 
LLC Federal Solutions

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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Drug Facts

Active Ingredient (in each teaspoonful)
Sennosides 8.8 mg

Purpose
Laxative

Uses
relieves occasional constipation (irregularity), generally produces bowel movement in 6-12 hours

Warnings

Ask a doctor before use if you have

• stomach pain
• nausea
• vomiting
• Noticed a sudden change in bowel movements that continues over a period of 2 weeks

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

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop use and ask a doctor if you have rectal bleeding or fail to have bowel movement after use of laxative. These may indicate a serious condition.

If pregnant or breast-feeding, ask a 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 right away.

Directions
Take preferably at bedtime or as directed by a doctor. Shake Well Before Using.

age	starting dose	maximum dosage
adults and children 12 years and older	2 - 3 teaspoons once a day	3 teaspoons twice a day
children 6 to under 12 years	1 - 1 1/2 teaspoons once a day	1 1/2 teaspoons twice a day
children 2 to under 6 years	1/2 - 3/4 teaspoon once a day	3/4 teaspoon twice a day
children under 2 years	ask a doctor	ask a doctor

Other information

• avoid excessive heat
• store at room temperature 15°- 30°C (59°- 86°F)

Inactive ingredients
cocoa distillate flavor, natural chocolate flavor, methylparaben, propylene glycol, propylparaben, purified water, sucrose

Questions? Call 1-855-333-6337
To Report suspected adverse reactions, contact the FDA at 1-800-FDA-1088

Repackaged by:
Safecor Health, LLC
317 New Boston St.
Woburn, MA 01801
Distributed by: LLC Federal Solutions
14 NE 1st Ave.
Miami, FL 33132

———PRINCIPAL DISPLAY PANEL———
NDC: 24451-289-05
SENNA SYRUP
(STANDARDIZED EXTRACT OF SENNA FRUIT)
DELIVERS 5 mL
CONTAINING:
SENNOSIDES 8.8 mg
ALCOHOL FREE
NATURAL CHOCOLATE FLAVOR
SHAKE WELL
Exp: 00/00/00 Lot # 00000

Rpk By: Safecor Health LLC
Woburn, MA 01801
Dist. By: LLC Federal Solutions
Miami, FL 33132

SENNA 
sennosides a and b syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24451-289(NDC: 0904-6289)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sennosides A and B (UNII: 1B5FPI42EN) (Sennosides A and B - UNII:1B5FPI42EN)	Sennosides A and B	8.8 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
COCOA (UNII: D9108TZ9KG)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor	CHOCOLATE (NATURAL CHOCOLATE FLAVOR)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24451-289-05	100 in 1 BOX	08/12/2013	12/31/2019
1		5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 24451-289-10	100 in 1 BOX	08/12/2013	12/31/2019
2		10 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	08/12/2013	12/31/2019

Labeler - LLC Federal Solutions (965036895)

Establishment
Name	Address	ID/FEI	Business Operations
Safecor Health, LLC		828269675	repack(24451-289)

Revised: 1/2020

Document Id: 2ae22434-2f6a-418b-a26f-9ce99b38788d

34390-5

Set id: cd5c6f7c-a658-47ef-9626-eb35cd3f10b6

Version: 2

Effective Time: 20200107