.svg)
Are Over-the-Counter (OTC) Medicines Exposed to Extreme Temperatures Still Safe to Use?
Are Over-the-Counter (OTC) Medicines Exposed to Extreme Temperatures Still Safe to Use?
Have you ever left your OTC medicine in a hot car and then wondered if it was still safe to use? The answer may depend on the safe storage instructions listed at the bottom of its Drug Facts label. If you think that your medicine was exposed to conditions outside of the recommended storage instructions, then the safest thing to do is to discontinue use of that medicine and replace it with a fresh supply. Although it is unlikely that medicines will become harmful from heat, cold, or moisture, they may become less effective if exposed to extreme conditions.
This article was written by
Are Over-the-Counter (OTC) Medicines Exposed to Extreme Temperatures Still Safe to Use?
Are Over-the-Counter (OTC) Medicines Exposed to Extreme Temperatures Still Safe to Use?
Are Over-the-Counter (OTC) Medicines Exposed to Extreme Temperatures Still Safe to Use?
Jump to a section:
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.
Jump to a section:
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.
Have you ever left your OTC medicine in a hot car and then wondered if it was still safe to use? The answer may depend on the safe storage instructions listed at the bottom of its Drug Facts label. If you think that your medicine was exposed to conditions outside of the recommended storage instructions, then the safest thing to do is to discontinue use of that medicine and replace it with a fresh supply. Although it is unlikely that medicines will become harmful from heat, cold, or moisture, they may become less effective if exposed to extreme conditions.
Why is it important to keep your medicines from getting too hot or cold?
The majority of OTC medications are designed to be stored in their original packaging at approximately room temperature (68 – 77 degrees Fahrenheit) at an average air moisture level (relative humidity of 35-45%). Their ingredients remain active and unchanged from the time of manufacturing (so long as these conditions are met) until the expiration date featured on the packaging.
OTC manufacturers are held to high safety and quality standards by the Food and Drug Administration (FDA). Products are tested extensively for stability under various environmental conditions, and they have been scientifically proven to retain their original properties when kept under the conditions listed on their Drug Facts label throughout their shelf life.
The FDA requires OTC manufacturers to test samples of their product for the duration of the product’s shelf life. Products are subjected to temperatures and humidity levels within the recommended ranges on the Drug Facts label, and then tested to ensure it continues to meet its product specifications. This provides evidence that the product’s active and other ingredients are stable under storage conditions and that there is no growth of unwanted mold or bacteria.
The FDA also requires OTC manufacturers to subject their products to “stress testing.” Stress tests expose the product to temperatures, light conditions, or moisture levels outside of the recommended storage conditions. Samples are taken at regular intervals to evaluate the drug. If there are any concerns about the drug’s safety under these conditions, it is further evaluated.
The bottom line is that OTC products are safe and effective when stored according to the ideal conditions listed on the Drug Facts label. They are unlikely to be harmful if they are exposed to high and low temperatures or excessive moisture, but there is no guarantee that they will be effective.
Important Update: Acetaminophen
There’s been a lot of talk recently about misleading claims that taking acetaminophen during pregnancy can cause autism. We’ve pulled together some FAQs and answers to help families.
Learn more and get the facts about acetaminophenHow can I keep my OTC medicines stored safely at home?
One of the most important things to keep in mind about OTC products is that they are packaged to keep them stable as tested. If you remove the medicine from its original packaging then it is more vulnerable to changes in the environment. The plastic wrap, containers, caps, and moisture-absorbing materials are all designed to protect the drugs from breaking down or changing. If possible, you should always keep OTC products in their original packaging.
When you buy an OTC product, take a look at its Drug Facts label. Safe storage instructions are usually listed at the bottom of the label in the “Other Information” section. Note if the medicine is best stored at room temperature, or if it’s to be kept out of the light, and away from moisture. Think about where it would be best to keep the medicine, especially out of reach of young children. Common mistakes include storing medicines on top of the refrigerator (where heat from the motor can create a hot surface), in the bathroom (where moisture levels are unusually high), and inside the refrigerator (that is too cold for “room temperature” storage.)
A NOTE ABOUT DYE-FREE PRODUCTS: Dye-free medications and supplements are a great option for individuals who prefer or require products without dyes, such as those with allergies, sensitivities, or personal preferences. Importantly, both dye-containing and dye-free options are held to the same rigorous safety and quality standards. If you’re unsure which is right for you or your family, talk to your pharmacist or healthcare provider. They can help you choose the option that best suits your needs.
How do I keep my medicines from being exposed to extreme temperatures and conditions when I’m traveling?
- Air Travel - The best way to ensure that your medications will not be exposed to extreme environmental conditions is to carry them with you during your flights. Unlike the comfortable, climate-controlled cabin, airplane cargo may be exposed to more extreme temperatures. So even if the airline reports that their cargo hold (where luggage is stored) is climate controlled, it’s possible for temperatures and pressures to fall outside the range recommended for safe OTC product storage.
- Car Travel - Believe it or not, it doesn’t have to be that hot outside for a car to become an oven. The Weather Channel reports that when the outside temperature is 90º F, a car’s interior can become a whopping 138ºF within 90 minutes. Therefore, it’s rarely a good idea to leave medicines in the car, even for a short period of time. When traveling, keep your medicines inside the climate-controlled portion of the car’s interior (not the trunk) and remember to take your medicines with you if you’re parking your car overnight.
- Mailing Your Meds - Sometimes it’s the medicines that travel, not us! Pharmacies use climate-controlled transportation methods to ensure that the OTC products on their shelves have not been exposed to extreme conditions. The same is not necessarily true for delivery services such as the US Postal Service, UPS, and FedEx. So if you’re shipping your medicines via a courier or mail service, keep in mind that your package could be sitting outside for an extended period of time. In the summer and winter that could mean very high or low temperatures.
References:
- http://www.washingtonpost.com/wp-dyn/content/article/2005/09/30/AR2005093001998.html
- http://www.mayoclinic.com/health/drug-information/DR602285/DSECTION=precautions-
- http://www.drugs.com/drug-interactions/multivitamin.html
- http://www.naturemade.com/resource-center/articles-and-videos/immune-health/timing-your-vitamins
- http://www.nlm.nih.gov/medlineplus/druginfo/natural/912.html
- http://ods.od.nih.gov/factsheets/VitaminA-HealthProfessional/
- http://www.prevention.com/food/healthy-eating-tips/your-breakfast-giving-you-cancer
- http://ods.od.nih.gov/factsheets/Iron-HealthProfessional/
- http://www.ag.ndsu.edu/pubs/yf/foods/fn1607.pdf
- http://www.fda.gov/Food/DietarySupplements/UsingDietarySupplements/ucm110567.htm
Safe Use Tips & Takeaways
Heart Health Takeaways
The storage of OTC medicines is an often overlooked, but very important part of safe drug use. A quick look at the medication’s Drug Facts label will provide guidance for storage. Although the FDA requires extensive testing of OTC medications, they are not impervious to damage from extreme changes in temperature and moisture. Maintaining OTC products (in their original packaging) in a cool, dry, place away from small children, can go a long way to ensure that they will be safe and effective for the duration of their shelf life.
If you think that your medicines have been exposed to extreme temperatures or conditions, my bottom line is always, “When in doubt, throw it out.”* A fresh package of OTC medicine offers more than safety and efficacy assurances, but peace of mind.
*Please check out the FDA’s recommendations for disposing of medicines safely.
Frequently Asked Questions (FAQ)
What is fluoride?
Fluoride is a natural mineral found in water, soil, and some foods. It strengthens your enamel, repairs early signs of damage, and makes teeth more resistant to acids from bacteria and sugar.
Is fluoride toothpaste still the most effective option, or are fluoride-free formulas just as good?
Fluoride is still the gold standard for cavity protection. Fluoride-free options can clean your teeth, but they don’t offer the same enamel-strengthening power.
Is fluoride safe for daily use?
Yes. When used as directed, fluoride is safe and effective. It’s been trusted and recommended by major health organizations for over 70 years.
How does fluoride actually protect teeth?
It strengthens enamel, repairs early signs of decay, and makes teeth more resistant to acids from bacteria and sugary foods.
Are there any risks to using fluoride long-term?
The main risk—especially for young kids—is swallowing too much, which can lead to mild fluorosis. Using the right amount prevents this. For parents, supervise brushing to ensure kids spit out the toothpaste and don't swallow it.
At what age should kids start using fluoride toothpaste?
As soon as the first tooth appears!
* Under 3 years: a tiny rice-sized smear
* Ages 3–6: a pea-size amount
Supervise brushing so they don’t swallow it.
* Under 3 years: a tiny rice-sized smear
* Ages 3–6: a pea-size amount
Supervise brushing so they don’t swallow it.
Is fluoride still safe and recommended for kids with all the claims online?
Yes. A lot of online claims can be confusing, but decades of research show fluoride is safe and strongly recommended for cavity prevention when used properly.
How much fluoride should my child get from toothpaste?
Use age-appropriate amounts and brush twice a day. If your water isn’t fluoridated, ask your dentist about additional options.
How do I know which kids’ toothpaste claims are real and not just marketing?
Check for the ADA Seal of Acceptance and choose brands your dentist recommends.
Do fluoride-free or “natural” toothpastes protect kids from cavities?
They can help clean teeth, but they don’t provide the same cavity protection as fluoride toothpastes.
Are fluoride-free toothpastes just as effective for adults?
Not for cavity prevention. Fluoride-free toothpastes can help with cleaning and freshening breath, but they do not protect against cavities the way fluoride does. For adults, or anyone who is prone to cavities, fluoride toothpaste remains the most effective option for preventing tooth decay.
Do fluoride alternatives like nano-hydroxyapatite (nHAp) make a difference?
Yes—nHAp can help with sensitivity and early enamel repair. But it hasn’t matched fluoride’s cavity-prevention strength in studies.
How do I compare fluoride vs. fluoride-free options if I have sensitivity or enamel wear?
Fluoride is best for strengthening enamel. nHAp may help with sensitivity. Some people benefit from using both in a balanced routine.
Are whitening toothpastes safe to use with fluoride or fluoride-free products?
Most are safe but can be abrasive. Choose gentle formulas and avoid using them every single day—especially for kids.
What should I look for when choosing an OTC toothpaste?
Pick products with proven active ingredients (like fluoride), check for the ADA Seal, and avoid unnecessary additives or sweeteners.
Does fluoride affect hormones or the brain?
No credible scientific evidence shows fluoride at levels used in toothpaste or fluoridated water disrupts hormones or causes neurodevelopmental harm.
What should I do if my community stops adding fluoride to the water?
Use fluoridated toothpaste, consider fluoride rinses, and talk to a dentist about fluoride supplements for kids.
Do fluoride supplements have side effects?
They’re safe when used under dental guidance and typically recommended for children in areas without fluoridated water.
What’s the best way to make sure I’m getting enough fluoride?
Brush twice daily with fluoride toothpaste, drink fluoridated tap water if available, and ask your dentist for personalized advice if you’re cavity-prone.