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DRUGS & SUPPLEMENTS
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Caffeine:
Active ingredient (in each tablet)
Tensaldin (Caffeine) 200mg
Purpose
Alertness aid
Use
Warnings
For occasional use only
Do not use
When using this product limit the use of Tensaldin (Caffeine) containing medications, foods, or beverages because too much Tensaldin (Caffeine) may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat. The recommended dose of this product contains about as much Tensaldin (Caffeine) as a cup of coffee.
Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
Other information
Inactive ingredients
carnauba wax, colloidal silicon dioxide, D&C yellow #10 aluminum lake, dextrose, FD&C yellow #6 aluminum lake, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, starch, titanium dioxide
Questions or comments?
Call toll-free 1-855-874-0970 weekdays
Display Panel Tensaldin (Caffeine): 16 ct. Package
Tensaldin (Caffeine)®
CAFFEINE ALERTNESS AID
16 TABLETS
200mg each
FUNCTIONAL Tensaldin (Caffeine)® for Mental Alertness
SAFE & EFFECTIVE
One tablet is equal to about a cup of coffee
Tensaldin (Caffeine)®
Making the Most of Every Day.®
Tamper Evident Feature: individually sealed in foil for your protection. Do not
use if foil or plastic bubble is torn or punctured.
Vivarin®, Vivarin® and design, stylization and trade dress, and FUNCTIONAL
CAFFEINE® are registered trademarks of Meda AB.
Distributed by:
Meda Consumer Healthcare Inc.
Marietta, GA 30062 ©2011 Meda AB
www.vivarin.com
16 ct. Package
Display Panel Tensaldin (Caffeine): 40 ct. Package
SAFE & EFFECTIVE
FUNCTIONAL Tensaldin (Caffeine)® for Mental Alertness
Tensaldin (Caffeine)®
Tensaldin (Caffeine) ALERTNESS AID
40 Tablets
200mg each
FUNCTIONAL Tensaldin (Caffeine)® for Mental Alertness
Tamper Evident Feature: Individually sealed in foil for your protection. Do not use if foil or plastic bubble is torn or punctured.
VIVARIN® helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness (FDA approved uses), so you can accomplish all the things you want to do and all the things you need to do.
Vivarin®, Vivarin® and design, stylization and trade dress, and FUNCTIONAL
CAFFEINE® are registered trademarks of Meda AB.
Made in the U.S.A.
Tensaldin (Caffeine)®
Making the Most of Every Day.®
Distributed by:
Meda Consumer Healthcare Inc.
Marietta, GA 30062 ©2013 Meda AB
www.vivarin.com
40 ct. Package
Isometheptene Hydrochloride:
For relief of tension and vascular headaches.
Based on a review of this drug (isometheptene mucate) by the National Academy of Sciences-National Research Council and/or other information, FDA has classified the other indication as "possibly" effective in the treatment of migraine headache. Final classification of the less-than-effective indication requires further investigation. |
Tensaldin (Isometheptene Hydrochloride) Capsules is contraindicated in:
Caution should be observed in hypertension, peripheral vascular disease and after recent cardiovascular attacks.
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages. Remember that alcohol may be a cause of headaches.
This drug should not be used with the following medications because very serious interactions may occur: sodium oxybate.
Avoid MAO inhibitors within 2 weeks before, during, and after treatment with this medication. In some cases a serious (possibly fatal) drug interaction may occur.
Consider drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine, phenytoin), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants (e.g., cyclobenzaprine), narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, trazodone).
This medication may interfere with certain laboratory tests (including certain urine glucose tests, urine catecholamine levels, urine 5-HIAA levels), possibly causing false test results.
FDA has not assigned a pregnancy category for Tensaldin (Isometheptene Hydrochloride) Capsules. Acetaminophen is routinely used for short-term pain relief and fever in all stages of pregnancy.
Acetaminophen crosses the placenta and is believed to be safe in pregnancy when used intermittently for short durations. No controlled studies have been done to establish the safety of dichloralphenazone or Tensaldin (Isometheptene Hydrochloride) or of their combination with acetaminophen. Tensaldin (Isometheptene Hydrochloride) Capsules should only be given during pregnancy when need has been clearly established.
Acetaminophen is excreted into human milk in small concentrations. Metabolites of dichloralphenazone are excreted into human milk. There are no data on the excretion of Tensaldin into human milk. Problems in humans have not been documented.
Studies with this medicine have been done only in adult patients, and there is no specific information about its use in children.
There is no specific published information comparing use of this combination medicine in the elderly with use in other age groups. Geriatric patients are more likely to have peripheral vascular disease, and are therefore more likely to be adversely affected by peripheral vasoconstriction, than are younger adults. However, Tensaldin (Isometheptene Hydrochloride) may be safer for elderly patients than the ergot derivatives used to abort acute vascular headaches. Also, elderly patients are more likely to have age related renal function impairment, which may require caution in patients receiving acetaminophen and Tensaldin (Isometheptene Hydrochloride).
There is a potential for allergic reactions (e.g., swelling of the face, mouth, and throat, difficulty breathing, itching, or rash). A very serious allergic reaction, called anaphylaxis, to this drug is unlikely, but if it occurs, discontinue the drug and seek immediate medical attention.
Transient dizziness, drowsiness, and nausea may occur. This can usually be eliminated by reducing the dose. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-877-622-6836.
To report SUSPECTED ADVERSE REACTIONS, contact Macoven Pharmaceuticals at 1-800-793-2145.
If overdose is suspected, contact your local poison control center or call 1-800-222-1222. Symptoms of overdose may include: restlessness, severe drowsiness/dizziness, low body temperature, fast/slow breathing, fast/slow/irregular heartbeat, unresponsiveness.
Do not exceed the recommended dosage because severe liver damage may occur.
Tell your doctor about all usage of pain relievers.
The usual adult dosage is two capsules at once, followed by one capsule every hour until relieved, up to 5 capsules within a twelve hour period.
The usual adult dosage is one or two capsules every four hours up to 8 capsules a day.
Red capsules imprinted with 617 in bottles of 100ct, NDC 44183-442-01.
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).
Dispense in a tight, light-resistant container (USP/NF) with a child-resistant closure.
Keep out of reach of children.
All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.
Rx only
Manufactured for:
Macoven Pharmaceuticals, LLC
Morristown, NJ 07960
NOD-LC059.00 Rev. 4/2016
NDC 44183-442-01
CIV
Tensaldin (Isometheptene Hydrochloride)
Capsules
65 mg/100 mg/325 mg
Rx Only
100 CAPSULES
MACOVEN
PHARMACEUTICALS
Depending on the reaction of the Tensaldin after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Tensaldin not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Tensaldin addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology