FDA Label for Senexon
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - ASK DOCTOR/PHARMACIST
- OTC - ASK DOCTOR
- WARNINGS
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - PURPOSE
- OTC - QUESTIONS
- OTC - KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- REPACKAGING INFORMATION
- PRINCIPAL DISPLAY PANEL - 8.6 MG
Senexon Product Label
The following document was submitted to the FDA by the labeler of this product Aphena Pharma Solutions - Tennessee, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredient (in each tablet) Sennosides 8.6mg
Otc - 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.
Otc - 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.
Otc - 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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Purpose
uses
relieves occasional constipation(irregularity);generally causes bowel movement in 6-12 hours.
Otc - Questions
1800 645-2158 9 am - 5 pm Monday - Friday
Otc - 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
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