SENNA by Aphena Pharma Solutions - Tennessee, LLC SENNA tablet, coated

SENNA by

Drug Labeling and Warnings

SENNA by is a Otc medication manufactured, distributed, or labeled by Aphena Pharma Solutions - Tennessee, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

INACTIVE INGREDIENT

DOSAGE & ADMINISTRATION

INDICATIONS & USAGE

WARNINGS

PURPOSE

KEEP OUT OF REACH OF CHILDREN

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

• Count: 8.6 mg
• 100: 71610-054-65

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:

Cookeville, TN 38506

20180427JH

PRINCIPAL DISPLAY PANEL - 8.6 mg

NDC: 71610-054 - Sennosides (Senna) 8.6 mg - Rx Only

INGREDIENTS AND APPEARANCE

SENNA 
senna tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71610-054(NDC: 0904-6434)
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	8.6 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)

Product Characteristics
Color	brown	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	TCL080
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71610-054-65	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/26/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	06/09/2015

Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)

Establishment
Name	Address	ID/FEI	Business Operations
Aphena Pharma Solutions - Tennessee, LLC		128385585	REPACK(71610-054)