Latest news with #Robitussin
Washington Post
4 days ago
- Health
- Washington Post
Melatonin doses can vary from what's on the label. Here's how much.
Food and Drug Administration researchers have identified dozens of melatonin supplements with doses well above or below the amount listed on the label. They analyzed 110 melatonin supplements purchased in 2023, focusing on ones marketed for children. Their study was first published in a peer-reviewed journal in October, but did not identify any of the products. The FDA's study is the largest of melatonin-containing products in the United States, the researchers noted in a peer-reviewed article on the results. The Washington Post filed a Freedom of Information Act request in November to obtain the names of the supplements tested, the results and any memo or report regarding the study. Among the supplements tested, researchers found that three products from Zarbee's, Robitussin and Creekside Natural Therapeutics varied the most from the melatonin declared, according to the documents from the FOIA request. Three other brands, WellYeah, Calmable and Nextdia, sold products that contained zero or close to zero detectable melatonin per serving, the documents show. Some pediatric sleep medicine specialists said melatonin should be treated like a prescribed medicine, not a supplement. They also advised that children should be given the smallest effective dose, starting at half a milligram, after parents have tried other ways to help them sleep. 'This is not a vitamin,' said Paul Gringras, a professor of sleep medicine at King's College in London and the president of the International Pediatric Sleep Association, a group that supports research on pediatric sleep medicine. 'It is the messenger that transmits a signal to keep our clock in time to virtually every organ in the body.' Tyish Hall Brown, the director of behavioral sleep medicine at Children's National Hospital in D.C., said reports of the variability in melatonin supplements are 'disconcerting.' But the dose in a serving is often still within what she considers an acceptable range (0.5 mg to 5 mg per serving) for a child or teenager, she said. 'We just have to be mindful of this inconsistency, and then monitor how they're reacting to the supplement that they're taking,' Hall Brown said. 'We should use the lowest dose that produces the desired effect.' Jeff Ventura, a spokesperson for the Council for Responsible Nutrition, a trade association for the supplement industry, said in an email that consumers — especially parents — should 'have access to products that are accurately labeled and responsibly manufactured.' Ventura also wrote that the findings 'reinforce the need for [the FDA] to take enforcement action against those companies that fail to meet these basic obligations.' To measure the ingredients, the FDA researchers compiled a list of 199 melatonin supplements sold in the United States. An FDA spokesperson said in an email that 'to mimic product searches of an average consumer, product selection was done through third-party online vendors using targeted keyword searches (e.g., 'Melatonin+Child').' The researchers froze and pulverized supplements to measure the melatonin. The FDA examined specific brands and dosages of products, providing documentation of the exact product tested. An FDA spokesperson did not respond to questions regarding the data provided or the researchers' conclusions in the study. The FDA spokesperson didn't say whether the agency has contacted companies regarding the test results but said in an email that the study's findings 'are being taken into consideration' as the agency evaluates the safety of melatonin supplements. Pieter Cohen, an associate professor of medicine at Harvard Medical School, who is a co-author of a 2023 letter in JAMA on melatonin supplements, said that his research and the FDA's study only provide a 'snapshot' regarding the melatonin in off-the-shelf supplements and that people shouldn't use the results to decide what brands to avoid buying. Cohen and other physicians recommend people search for melatonin supplements that are third-party-tested by U.S. Pharmacopeia (USP). A spokesperson for Kenvue, the maker of Zarbee's, said Zarbee's Sleep with Melatonin 'is an adult product' that has been discontinued 'at most major retailers but is still available online.' Sam Osborne, a managing partner for Creekside Natural Therapeutics, whose product had six times the amount of melatonin on the label, said in an email that the FDA's results 'were both a surprise and a disappointment to us.' 'We have removed the fruit chews from the market and discontinued our business with the contract manufacturer who made those products for us,' Osborne said. A spokesperson for Haleon, the company that owns Robitussin, said the Robitussin Naturals product line mentioned in the study, which had four times the amount of melatonin on the label, has been discontinued. A spokesperson for Kenvue said in a statement that 'the FDA permits the inclusion of some amount of overage to ensure that the product contains at least 100% of the ingredient quantity listed on the label throughout its shelf life.' Patti Zettler, a professor of law at Ohio State University, said in an email that the FDA 'has recognized' some supplement companies design products to have an additional amount of an ingredient 'so that the product has at least 100% of the claimed amount of the ingredient throughout its shelf life.' 'But companies also have an obligation under the law to ensure that their products meet safety standards,' Zettler said. Neal Fortin, a professor and the director of the Institute for Food Laws & Regulations at Michigan State University, said companies 'should know their product' and the degree to which the active ingredients in dietary supplement degrade over time. 'If they're relying on putting a whole bunch in extra just so you make sure you get what you have, that's bad manufacturing practices,' Fortin said. 'That's not allowed.' Supplement companies could either reformulate their product for more stability or shorten its shelf life so they don't have overages, Fortin said. 'Some of these things can be dangerous if they're in large amounts — or larger than expected,' he said. People associated with the companies behind the brands Calmable, Doctor's Finest and WellYeah did not respond to requests for comments. A representative for Nextdia declined to comment. Mike Poll, a senior purchaser for Nutrabulk, one of the three brands with the correct dosage, said in an email 'we are pleased but not surprised' by the results of the FDA study. Melatonin is a hormone our brain releases at night to regulate the body's sleep-wake cycle, or circadian rhythm. Melatonin supplements help a person transition to bedtime, but it is not a sedative, Hall Brown said. When someone is having a hard time falling asleep at an earlier bedtime, melatonin supplements can help them adjust their circadian rhythm, she said. For example, people often take melatonin to manage jet lag. Melatonin is considered a dietary supplement in the United States. The FDA doesn't regulate dietary supplements as rigorously as it does prescription medications, or test them for safety and efficacy. In recent years, more adults have started taking melatonin supplements before bedtime, and some parents give them to children, although the practice isn't universally supported. Melatonin supplements are generally considered safe for children older than 2 years old to take in small doses for short periods of time — days, not weeks or months, states the International Pediatric Sleep Association. But one survey showed that parents of school-age children were giving melatonin to their kids for 18 months, on average. Studies have found that melatonin can help children with autism or attention-deficit/hyperactivity disorder fall asleep faster and sleep longer. But there's limited evidence supporting use for other children, and less is known regarding long-term use of the supplements. Some physicians are concerned melatonin supplements could affect children's growth and development. 'We're selling an active hormone, we're giving it to our children, and we have no idea how much we're giving them,' Cohen said. 'We don't know the long-term effects — at all — of this product,' said Cora Collette Breuner, a professor of pediatrics at the University of Washington School of Medicine and member of the American Academy of Pediatrics. The American Academy of Pediatrics states melatonin 'should only be used' in consultation with a pediatrician and after establishing other healthy sleep habits. Muhammad Rishi, an associate professor of medicine at Indiana University School of Medicine and spokesperson for the American Academy of Sleep Medicine, said that 'the public needs to understand that melatonin is not a dietary supplement.' Other physicians said melatonin can help some children. 'Sometimes the benefits of helping a child sleep outweigh the minor risks, as long as you're treating it like a drug,' said Beth Malow, a professor of neurology and pediatrics at Vanderbilt University Medical Center who has conducted research on melatonin for children with autism. 'Using behavioral interventions is best, but it's not always possible.' Hall Brown said she works with parents to implement behavioral techniques first, such as having a consistent bedtime. Then she'll recommend melatonin as 'a second line of defense.' The side effects of melatonin supplements are typically mild but they are associated with vivid dreams, bed-wetting, grogginess, headaches and dizziness. All the physicians interviewed advised parents to consult a health care provider before giving a child melatonin. Children tend to fall asleep faster if they have a consistent bedtime and an evening wind-down routine. You can also create a 'cave-like' environment for the child that's cool and dark, Gringras said. Limit light and light-emitting devices such as tablets or phones because the light can suppress the brain's release of melatonin. The American Academy of Pediatrics recommends children avoid screens for at least one hour before bedtime. Parents who do try melatonin should employ a 'two-pronged approach,' pairing the drug with a bedtime routine, because the melatonin won't work forever, Gringras said. 'When it stops working,' he said, 'you want the young person to have learned good behavioral habits that will last for the rest of their life.' Aaron Schaffer contributed to this report.
Health Line
27-05-2025
- General
- Health Line
How to Sleep with a Cough: Tips for a Restful Night
If you experience nighttime coughs, you may want to try increasing the humidity or elevating your head and neck to ease your symptoms. Some OTC medications can also help. It's late. You'd like to be sound asleep — but every time you begin to drift off, a cough jolts you awake again. A nighttime cough can be disruptive and frustrating. You need to sleep so you can get the rest you need to fight your illness and function during the day. But your nagging cough won't let you get the elusive sleep you so badly need. So, what can you do to conquer your cough at night? In this article, we'll look at some possibilities you may want to consider for different types of coughs, including wet and dry coughs and those ticklish back-of-the-throat ones. How to calm a wet cough Wet coughs, which are sometimes called productive coughs, often involve excessive mucus in the chest, throat, and mouth. Elevate your head and neck Sleeping flat on your back or on your side can cause mucus to build up in your throat, which can trigger a cough. To avoid this, stack a couple of pillows or use a wedge to lift your head and neck slightly. Avoid elevating your head too much, as this could lead to neck pain and discomfort. Try an expectorant Expectorants thin the mucus in your airways, making it easier to cough up phlegm. The only Food and Drug Administration (FDA)-approved expectorant in the United States is guaifenesin, which is marketed under brand names like Mucinex and Robitussin DM. Drink a warm beverage A steamy, warm beverage may help soothe a throat that's become irritated from coughing and also loosen up mucus. Warm water with honey and lemon, herbal teas, and broths are all good options. Be sure to finish drinking any beverage at least an hour before bedtime. Take a hot shower Steam from a warm shower may help loosen mucus in your chest and sinuses, clearing your airways. How to soothe a dry cough Dry coughs may be related to conditions like GERD, asthma, postnasal drip, ACE inhibitors, and upper respiratory infections. Less commonly, dry coughs could be caused by whooping cough. Try a lozenge Throat lozenges can be found at drugstores and retailers, and they come in an assortment of flavors. Some lozenges may contain menthol to help open up your sinuses. Some also contain vitamin C or medications that can soothe a sore throat. Whichever one you try, be sure to finish the lozenge before you lie down so you don't choke on it. Avoid giving lozenges to young children as they can be a choking hazard. Consider a decongestant Decongestants can help dry up the postnasal drip that can cause that nagging nighttime cough. Decongestants are not safe for people who have high blood pressure or children younger than 12. Look into a cough suppressant Cough suppressants, which are also known as antitussives, prevent coughing by blocking your cough reflex. They can be helpful for dry nighttime coughs, as they may stop your cough reflex from being triggered while you sleep. Drink plenty of fluids Staying hydrated is especially important when you're feeling under the weather. Drinking fluids throughout the day can help keep your throat lubricated, which can help protect it from irritants and other coughing triggers. Aim to drink at least 8 glasses of water a day. Just be sure to stop drinking fluids at least an hour before bedtime to avoid bathroom trips during the night. How to ease a tickly cough If your cough is caused by allergies or postnasal drip, an itchy or tickly cough may keep you awake. Use a humidifier Air that's too dry can irritate your throat and send you into a flurry of coughing. One word of caution: Be careful not to overdampen the air. Allergens like dust mites and mold can worsen in wet air, and asthma can sometimes be worsened by dampness. To make sure the humidity level in your sleeping space is at or near the recommended level of 50%, consider using a hygrometer to measure the exact level of moisture in the air. Keep your bedding clean The American Academy of Asthma, Allergy, and Immunology recommends that you wash your sheets, mattress covers, blankets, and pillowcases in hot water at 130°F (54.4°C) or higher, once a week. If you're allergic to pet dander or pet saliva, it might be best to get your cuddles during the day and keep pets out of your bedroom at night. Try an oral antihistamine Consult with a healthcare professional about whether your cough would respond to an OTC or prescription medication that blocks your body's production of histamines or acetylcholine, both of which stimulate coughing. Understanding what can cause a cough A cough can be caused by a wide variety of conditions and circumstances. If you understand the cause of your cough, it may be easier for you to choose an effective remedy. These conditions and factors are all known to cause coughing: asthma allergies viruses like colds and flu bacterial infections like pneumonia and bronchitis postnasal drip smoking certain medications, such as ACE inhibitors, beta-blockers, and some nonsteroidal anti-inflammatory drugs (NSAIDs) chronic obstructive pulmonary disorder (COPD) gastroesophageal reflux disease (GERD) cystic fibrosis whooping cough If you're not sure why you're coughing, a doctor can order chest X-rays, lab tests, scope tests, or CT scans to find out what's triggering your cough. Consider getting a whooping cough vaccination, and if you smoke, know that quitting may improve your cough in as little as 8 weeks. When to consult a doctor or other healthcare professional In most cases, a cough that's caused by an infection or irritant will usually clear up within a few weeks with home remedies or over-the-counter (OTC) medication. But there may be times when a cough is more serious. Make an appointment with a healthcare professional if: your cough lasts longer than 3 weeks your cough turns from dry to wet you're coughing up increased amounts of phlegm you also have a fever, shortness of breath, or vomiting you're wheezing your ankles are swollen you're experiencing unintentional or unexplained weight loss Seek immediate medical attention if you have a cough and: have trouble breathing cough up blood or pink-tinged mucus have chest pains Optum Perks is owned by RVO Health. By clicking on this link, we may receive a commission. Learn more. Frequently asked questions How can I stop coughing at night? Some short-term remedies for a wet cough may include taking an expectorant, swallowing honey, and drinking a warm beverage before bed. For a dry cough, you can try sucking on a lozenge and taking a decongestant before bed, as well as elevating your head while you sleep. If your cough persists or your symptoms worsen, speak with a doctor. They can diagnose the underlying cause and provide a treatment plan that's right for you. Some short-term remedies for a wet cough may include taking an expectorant, swallowing honey, and drinking a warm beverage before bed. For a dry cough, you can try sucking on a lozenge and taking a decongestant before bed, as well as elevating your head while you sleep. If your cough persists or your symptoms worsen, speak with a doctor. They can diagnose the underlying cause and provide a treatment plan that's right for you. What is the best position to sleep in when you have a cold and cough? Avoid lying flat on your back if you have a cough. This may cause mucus to accumulate in your throat, triggering a cough. Instead, try keeping your head and neck elevated. You can stack some pillows or plush items to create an elevated surface to rest your head and neck on. Avoid lying flat on your back if you have a cough. This may cause mucus to accumulate in your throat, triggering a cough. Instead, try keeping your head and neck elevated. You can stack some pillows or plush items to create an elevated surface to rest your head and neck on. Can lying on your stomach help with a cough? Lying on your stomach with your back end elevated may help drain your lungs, but it's unlikely to relieve a cough. It may actually make the pressure in your sinuses worse. Lying on your stomach with your back end elevated may help drain your lungs, but it's unlikely to relieve a cough. It may actually make the pressure in your sinuses worse.
Miami Herald
15-04-2025
- Business
- Miami Herald
Robitussin sued over non-drowsy claims. Are you owed part of $4.5M settlement?
Robitussin owes some cold sufferers money as part of a class-action settlement. The cough medicine brand has agreed to pay $4.5 million to resolve claims that it duped consumers by marketing its products as 'non-drowsy,' according to the settlement website. A complaint filed in June 2022 said calling those products non-drowsy is 'false and misleading,' arguing that Robitussin contains dextromethorphan, a cough suppressant commonly found in over-the-counter medicines. While rare, side effects can include drowsiness and dizziness, according to the National Institutes of Health. 'Consumers rely on this 'Non-Drowsy' medicine when they are driving, working, and supervising their children (when being drowsy would be problematic or even dangerous),' the lawsuit says. 'But the truth is that the Non-Drowsy Robitussin Products do cause drowsiness, and Defendants know this.' Pharmaceutical firm Haleon, the maker of Robitussin, has denied wrongdoing. McClatchy News reached out to the company for comment April 15 and was awaiting a response. Going forward, Haleon has agreed to stop labeling certain Robitussin products as 'non drowsy' and will 'exclude that statement from any future marketing,' according to the settlement website. Affected buyers have until May 12 to file a claim. Here's what to know: Who's eligible? Anyone in the U.S. who bought any flavor Robitussin product containing dextromethorphan (or DXM) and labeled as 'non-drowsy' between Feb. 16, 2016, and Jan. 21 are eligible to file a claim, according to the settlement website. How do I file a claim? Claim forms can be completed and submitted online or mailed, administrators said. Under the terms of the settlement, buyers with a qualifying proof of purchase may file up to three claims while those without it are limited to one claim per household. All claims must be postmarked or submitted by Monday, May 12. How much is the payment? Buyers can expect to receive between $1.50 and $4.75 per claim, though amounts may be higher or lower depending on the number of valid claims filed, the settlement website says. When will I get paid? Buyers who submit a valid and timely claim will be paid after a court approves the settlement, barring any appeals, according to the administrator's website. A hearing to finalize the terms is scheduled for Monday, June 30. 'It's always uncertain how these appeals will be resolved and resolving them can take time,' administrators said. 'Please be patient.'
