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Americans aren’t sleeping well. Roughly 80% of U.S. adults say they struggle to fall asleep at least one night a week, according to a recent Consumer Reports survey. And research has found that sleep problems are also on the rise among adolescents.

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While the causes of America’s sleep woes are up for debate, there’s little disagreement about America’s favorite remedy: Melatonin, by far the country’s most-used sleep aid.

What is Melatonin?

Melatonin is a hormone that plants and animals, including humans, produce naturally. The melatonin sold in over-the-counter pills is synthetic, but chemically it’s the same as the stuff the human body makes. It can, if used properly, help certain problem sleepers get to bed at night.

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Melatonin hormone secreted by pineal gland (red) at night, regulates body's daily biological rhythm depending on luminosity as light regulates its secretion via a path involving the suprachiasmatic nucleus (green), the paraventricular nucleus (yellow) and the preganglionic sympathetic neurons.

Research has also shown it can help combat inflammation, promote weight loss, and maybe even help children with neurodevelopmental disorders. That’s a lot to claim, though there are some studies to back up the various benefits. One 2011 review found evidence that, in children with autism, melatonin supplementation led to improved sleep and better daytime behavior. A small 2017 study from Poland found that obese adults who took a daily 10 mg melatonin supplement for 30 days while eating a reduced-calorie diet lost almost twice as much weight as a placebo group. The underlying cause might be connected to the fact that blood measures of oxidative damage and inflammation were much lower in the people who took melatonin.

“Some of the emerging science is showing that in people with higher levels of inflammation—which could be because they’re obese, or because they’re in the [intensive care unit] for a transplant—melatonin in the range of 6 mg to 10 mg may decrease markers of inflammation,” says Helen Burgess, a professor of psychiatry and co-director of the Sleep and Circadian Research Laboratory at the University of Michigan. If someone is healthy, it’s not clear that high-dose melatonin has a similar anti-inflammation effect, she adds. But it’s possible.

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Burgess is one of the country’s foremost melatonin researchers. She says that the traditional view of melatonin is that it plays a role in regulating the body’s internal day-night clocks, which is why it can help people sleep. “But there’s a theory that melatonin’s original purpose was as an antioxidant, which is what it does in plants,” she says. This alternative theory holds that it was only later in human evolution that melatonin took on a secondary role as a biological clock-setter.

Inflammation, like poor sleep, is implicated in the development or progression of an array of diseases, from heart disease and diabetes to depression and dementia. If melatonin could safely promote both better sleep and lower rates of inflammation, it could be a potent preventative for a lot of those ills. And melatonin appears to be safe—though there isn’t much research on the long-term effects of taking it in heavy doses.

What is a safe melatonin dose?

According to Michael Grandner, director of the Sleep and Health Research Program at the University of Arizona, “melatonin is very safe if taken in normal doses,” which is anything between 0.5 mg and 5 mg.

A 0.5 mg dose may be all that’s needed for sleep-cycle regulation, and should be taken three to five hours before bed, he says. For people who want to take melatonin just before bed, a 5 mg dose is appropriate. “Some people report headaches or stomach problems at higher doses, but those side-effects are uncommon,” he says.

Still, there are other concerns. “Melatonin has an incredible safety record, no doubt about it,” says Dr. Mark Moyad, the Jenkins/Pomkempner director of preventive and alternative medicine at the University of Michigan. “But it’s a hormone, and you don’t want to mess around with hormones until you know what they’re doing.”

People with existing medical problems should discuss melatonin with their doctor before using it. While some research has found that melatonin may help treat hyperglycemia in people with diabetes, for example, other studies have shown that, in diabetes patients who carry certain genetic traits, melatonin may interfere with glucose regulation. It’s these sorts of contradictory findings that give experts pause when it comes to issuing melatonin a full-throated endorsement.

“My advice is always to treat supplements like drugs, meaning don’t take a pill unless you need a pill,” Moyad says. He urges restraint with melatonin not because there’s evidence it’s dangerous, but because of the lack of evidence showing it’s safe in high doses over long periods. Especially for parents who are giving melatonin to healthy children, Moyad says caution is warranted. Melatonin appears to be safe, and it could provide a range of health benefits. But there are a lot of unknowns.

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What is Alka-Seltzer Plus Cold?

Acetaminophen is a pain reliever and fever reducer.

Chlorpheniramine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Alka-Seltzer Plus Cold is a combination medicine used to treat headache, fever, body aches, runny or stuffy nose, sneezing, itching, watery eyes, and sinus congestion caused by allergies, the common cold, or the flu.

Alka-Seltzer Plus Cold may also be used for purposes not listed in this medication guide.

Important Information

Do not use Alka-Seltzer Plus Cold if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

In rare cases, acetaminophen may cause a severe skin reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Before taking this medicine

You should not use this medication if you are allergic to acetaminophen, chlorpheniramine, or phenylephrine.

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have other medical conditions, especially:

asthma or COPD, cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;
a blockage in your stomach or intestines;
liver disease, alcoholism, or if you drink more than 3 alcoholic beverages per day;
kidney disease;
high blood pressure, heart disease, coronary artery disease, or recent heart attack;
enlarged prostate or urination problems;
glaucoma;
diabetes;
overactive thyroid;
pheochromocytoma (an adrenal gland tumor); or
if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

It is not known whether Alka-Seltzer Plus Cold will harm an unborn baby. Do not use this medicine without your doctor's advice if you are pregnant.

This medication may pass into breast milk and may harm a nursing baby. Antihistamines and decongestants may also slow breast milk production. Do not use this medicine without your doctor's advice if you are breast-feeding a baby.

How should I take Alka-Seltzer Plus Cold?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. This medicine is usually taken only for a short time until your symptoms clear up.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Drop the effervescent tablets into a glass of water (at least 4 ounces, or one-half cup). Stir this mixture and drink all of it right away.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days.

Store at room temperature away from moisture and heat. Do not allow liquid medicine to freeze.

What happens if I miss a dose?

Since Alka-Seltzer Plus Cold is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1 800 222 1222. An overdose of acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

What should I avoid while taking Alka-Seltzer Plus Cold?

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen, and can increase certain side effects of chlorpheniramine.

This medicine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Alka-Seltzer Plus Cold side effects

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

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking Alka-Seltzer Plus Cold and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Stop using this medicine and call your doctor at once if you have:

chest pain, rapid pulse, fast or uneven heart rate;
confusion, hallucinations, severe nervousness;
tremor, seizure (convulsions);
easy bruising or bleeding, unusual weakness;
little or no urinating;
nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes); or
dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, shortness of breath, uneven heartbeats, seizure).

Side effects such as dry mouth, constipation, and confusion may be more likely in older adults.

Common side effects may include:

dizziness, drowsiness;
mild headache, blurred vision;
dry mouth, nose, or throat;
constipation;
feeling nervous; or
sleep problems (insomnia);

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.

What other drugs will affect Alka-Seltzer Plus Cold?

Ask a doctor or pharmacist before using this medicine if you are also using any other drugs, including prescription and over-the-counter medicines, vitamins, and herbal products. Some medicines can cause unwanted or dangerous effects when used together. Not all possible interactions are listed in this medication guide.

Taking this medicine with other drugs that make you sleepy or slow your breathing can worsen these effects. Ask your doctor before taking Alka-Seltzer Plus Cold with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

More about Alka-Seltzer Plus Cold (acetaminophen / chlorpheniramine / phenylephrine)

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Consumer resources

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