Melatonin and pyridoxine

Melatonin and pyridoxine is likely effective in alternative medicine as an aid for occasional sleeplessness and can help you fall asleep and stay asleep.

It is not certain whether melatonin and pyridoxine is effective in treating any medical condition. The FDA has not approved the medicinal use of this product. Melatonin and pyridoxine should not be used as a substitute for medication prescribed by your doctor.

Melatonin and pyridoxine is often sold as an herbal supplement. Many herbal compounds do not have regulated manufacturing standards, and some supplements may be contaminated with toxic metals or other drugs. It is important to buy herbal/health supplements from a reliable source to reduce the risk of contamination.

Melatonin and pyridoxine may also be used for purposes that are not listed in this product guide.

When thinking about using melatonin and pyridoxine, talk to your doctor. You may also want to consult a practitioner who knows about herbal and health supplements.

If you decide to use melatonin and pyridoxine, follow the instructions on the package or the advice from your doctor, pharmacist, or other healthcare provider. Do not take more of this product than what is recommended on the label.

Melatonin and pyridoxine is taken once a day, 20 minutes before bedtime.

Swallow the extended-release tablet whole and do not crush, chew, or break it.

Store at a cool room temperature, away from moisture and heat.

Follow all instructions on the label and package. Inform each of your healthcare providers about all your medical conditions, allergies, and all medicines you are using.

Before using melatonin and pyridoxine, speak with your healthcare provider. You might not be able to use this product if you have specific medical conditions.

Check with a doctor, pharmacist, or other healthcare provider if it is safe for you to use this product if you have or have ever had:

• an autoimmune disorder; or
• a depressive disorder.

Consult a doctor before using this product if you are pregnant or breastfeeding.

Do not give any herbal/health supplement to a child without medical advice.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Although not all side effects are known, melatonin and pyridoxine is thought to be possibly safe when taken for a short period of time.

Common side effects of melatonin and pyridoxine may include:

• headache;
• upset stomach; or
• daytime drowsiness or "hangover" feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Melatonin and pyridoxine is used as needed. If you are on a dosing schedule and miss a dose, skip that dose. Do not take two doses at once.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Ask a doctor or pharmacist before using over-the-counter medicines that may contain ingredients similar to melatonin and pyridoxine.

Avoid driving or hazardous activity until you know how this product will affect you. Drowsiness can cause falls, accidents, or severe injuries.

Drinking alcohol with melatonin and pyridoxine can cause side effects.

Taking melatonin and pyridoxine with other medications that cause drowsiness can make you feel even sleepier. Talk to your doctor before using sleep medicines, muscle relaxants, or other drugs that make you drowsy.

Other medications may also impact how melatonin and pyridoxine work, including both prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are using.