OTC Medication Information: SENEXON

SENEXON — 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.

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

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
(click image for full-size original)

SENEXON
senna tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71610-058(NDC:0536-5904)
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
HYPROMELLOSE 2910 (6 MPA.S)
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:71610-058-65 100 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 02/09/2006
Labeler — Aphena Pharma Solutions — Tennessee, LLC (128385585)
Establishment
Name Address ID/FEI Operations
Aphena Pharma Solutions — Tennessee, LLC 128385585 REPACK (71610-058)

Revised: 05/2018 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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