SENEXON - senna 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.

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Active ingredient (in each tablet) Sennosides 8.6mg

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

Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts over two weeks.

Do not use for longer than one week, when abdominal pain, nausea or vomiting are present.

Stop use and ask a doctor if: you have rectal bleeding; you fail to have a bowel movement after use of this product.  These may indicate a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

uses

relieves occasional constipation(irregularity);generally causes bowel movement in 6-12 hours.

1800 645-2158 9 am - 5 pm Monday - Friday

 Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

Inactive Ingredients croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, minerol  oil

Dosage and Administration

Adults and children 12 years and over - 2 tablets once a day - maximum dosage - 4 tablets twice a day

Children 6 to under 12 years - 1 tablet once a day maximum dosage - 2 tablets twice a day

children 2 to under 6 years - 1/2 tablet once a day - maximum dosage - 1 tablet twice a day

Relieves occasional constipation

Generally produces bowel movement in 6-12 hours

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
10071610-058-65

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

20180514JH

PRINCIPAL DISPLAY PANEL - 8.6 mg

NDC 71610-058 - Sennosides (Senna) 8.6 mg
Bottle Label 8.6 mg

SENEXON 
senna tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71610-058(NDC:0536-5904)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SENNOSIDES A and B (UNII: 1B5FPI42EN) (SENNOSIDES A and B - UNII:1B5FPI42EN) SENNOSIDES A and B8.6 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
magnesium stearate (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
mineral oil (UNII: T5L8T28FGP)  
Product Characteristics
ColorbrownScoreno score
ShapeROUNDSize9mm
FlavorImprint Code TCL080
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71610-058-65100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/04/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33402/09/2006
Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
Establishment
NameAddressID/FEIBusiness Operations
Aphena Pharma Solutions - Tennessee, LLC128385585REPACK(71610-058)

Revised: 5/2018
Document Id: 81c8d20a-3679-423a-8916-a1e5dcde0fbf
Set id: 18c77552-9e65-4e73-9e41-59f91075ce94
Version: 1
Effective Time: 20180514
 
Aphena Pharma Solutions - Tennessee, LLC