OTC Medication Information: SENNA

SENNA- sennosides a and b tablet, coated
Aphena Pharma Solutions — Tennessee, LLC

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.

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:

Count8.6 mg
10071610-054-65

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:
Aphena Pharma Solutions -- TN
Cookeville, TN 38506
20180427JH

PRINCIPAL DISPLAY PANEL — 8.6 mg

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

Bottle Label 8.6 mg
(click image for full-size original)

SENNA
senna tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71610-054(NDC:0904-6434)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SENNOSIDES A AND B (SENNOSIDES A AND B) SENNOSIDES A AND B 8.6 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
MINERAL OIL
Product Characteristics
Color brown Score no score
Shape ROUND Size 9mm
Flavor Imprint Code TCL080
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71610-054-65 100 TABLET, COATED in 1 BOTTLE, PLASTIC None
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 Operations
Aphena Pharma Solutions — Tennessee, LLC 128385585 REPACK (71610-054)

Revised: 04/2018 Aphena Pharma Solutions — Tennessee, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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