Tensaldin

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Tensaldin uses

Tensaldin consists of Caffeine, Isometheptene Hydrochloride, Isometheptene Mucate, Metamizole.

Caffeine:



Active ingredient (in each tablet)

Tensaldin (Caffeine) 200mg

Purpose

Alertness aid

Use

  • helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Warnings

For occasional use only

Do not use

  • in children under 12 years of age
  • as a substitute for sleep

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

  • adults and children 12 years of age and over: take 1 tablet not more often than every 3 to 4 hours.

Other information

  • store at room temperature
  • avoid excessive heat (greater than 100°F) or humidity

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:


INDICATIONS AND USAGE

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.

CONTRAINDICATIONS

Tensaldin (Isometheptene Hydrochloride) Capsules is contraindicated in:

  • Hypersensitivity or intolerance to any component of this product
  • Cardiovascular or cerebrovascular insufficiency, including recent myocardial infarction or stroke
  • Glaucoma
  • Severe cases of renal disease
  • Hypertension
  • Organic heart disease
  • Peripheral vascular disease
  • Hepatic disease
  • Those patients who are on monoamine-oxidase (mao) inhibitor therapy

PRECAUTIONS

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.

DRUG INTERACTIONS

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.

PREGNANCY

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.

NURSING MOTHERS

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.

PEDIATRIC USE

Studies with this medicine have been done only in adult patients, and there is no specific information about its use in children.

GERIATRIC

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).

ADVERSE REACTIONS

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.

OVERDOSAGE

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.

DOSAGE AND ADMINISTRATION

Do not exceed the recommended dosage because severe liver damage may occur.

Tell your doctor about all usage of pain relievers.

FOR RELIEF OF MIGRAINE HEADACHE

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.

FOR RELIEF OF TENSION HEADACHE

The usual adult dosage is one or two capsules every four hours up to 8 capsules a day.

HOW SUPPLIED

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

Tensaldin pharmaceutical active ingredients containing related brand and generic drugs:


Tensaldin available forms, composition, doses:


Tensaldin destination | category:


Tensaldin Anatomical Therapeutic Chemical codes:


Tensaldin pharmaceutical companies:


References

  1. Dailymed."VIVARIN (CAFFEINE) TABLET [MEDA CONSUMER HEALTHCARE INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."CAFFEINE; ERGOTAMINE TARTRATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "caffeine". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Tensaldin?

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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sdrugs.com conducted a study on Tensaldin, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Tensaldin consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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