SENEXON- senna tablet, coated

SENEXON by

Drug Labeling and Warnings

SENEXON 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

Active ingredient (in each tablet) Sennosides 8.6mg

ASK DOCTOR/PHARMACIST

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 DOCTOR

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

WARNINGS

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

STOP USE

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.

PREGNANCY OR BREAST FEEDING

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

PURPOSE

uses

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

QUESTIONS

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

KEEP OUT OF REACH OF CHILDREN

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

INACTIVE INGREDIENT

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

DOSAGE & ADMINISTRATION

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

INDICATIONS & USAGE

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:

• Count: 8.6 mg
• 100: 71610-058-65

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:

Cookeville, TN 38506

20180514JH

PRINCIPAL DISPLAY PANEL - 8.6 mg

NDC: 71610-058 - Sennosides (Senna) 8.6 mg

INGREDIENTS AND APPEARANCE

SENEXON 
senna tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71610-058(NDC: 0536-5904)
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)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
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: 71610-058-65	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/04/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	02/09/2006

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

Establishment
Name	Address	ID/FEI	Business Operations
Aphena Pharma Solutions - Tennessee, LLC		128385585	REPACK(71610-058)