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MELATONIN (mel uh TOH nin) is a dietary supplement. It is promoted to help maintain normal sleep patterns. The FDA has not approved this supplement for any medical use.
This supplement may be used for other purposes; ask your health care provider or pharmacist if you have questions.
They need to know if you have any of these conditions:
if you frequently drink alcohol containing drinks
immune system problems
an unusual or allergic reaction to melatonin, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
Take this supplement by mouth with a glass of water. Follow the directions on the package labeling, or take as directed by your health care professional. Do not chew or crush this medicine. Do not take this medicine more often than directed.
Talk to your pediatrician regarding the use of this supplement in children. This supplement is not recommended for use in children.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
This does not apply; this medicine is not for regular use. Do not take double or extra doses.
Check with your doctor or healthcare professional if you are taking any of the following medications:
medicines for blood pressure like nifedipine
medications for anxiety, depression, or other emotional or psychiatric problems
medications for seizures
medications for sleep
other herbal or dietary supplements
stimulant medicines like amphetamine, dextroamphetamine
treatments for cancer or immune disorders
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
See your doctor if your symptoms do not get better or if they get worse. Do not take this supplement for more than 2 weeks unless your doctor tells you to.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.
Talk to your doctor before you use this supplement if you are currently being treated for an emotional, mental, or sleep problem. This medicine may interfere with your treatment.
Herbal or dietary supplements are not regulated like medicines. Rigid quality control standards are not required for dietary supplements. The purity and strength of these products can vary. The safety and effect of this dietary supplement for a certain disease or illness is not well known. This product is not intended to diagnose, treat, cure or prevent any disease.
The Food and Drug Administration suggests the following to help consumers protect themselves:
Always read product labels and follow directions.
Natural does not mean a product is safe for humans to take.
Look for products that include USP after the ingredient name. This means that the manufacturer followed the standards of the US Pharmacopoeia.
Supplements made or sold by a nationally known food or drug company are more likely to be made under tight controls. You can write to the company for more information about how the product was made.
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
depressed, nervous, or other mood changes
fast or pounding heartbeat
trouble staying awake or alert during the day
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Keep out of the reach of children.
Store at room temperature or as directed on the package label. Protect from moisture. Throw away any unused supplement after the expiration date.