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Nicotine is available in over-the-counter (OTC) medicines that reduce withdrawal symptoms associated with quitting smoking, including nicotine craving. They have been found to be most effective when a smoker who wants to quit completes the program as recommended on the product labeling.
Symptoms Treated
Symptoms Treated
No items found.
More specifically:
Reduces withdrawal symptoms and nicotine cravings
Common Products
- Commit®
- Habitrol®
- NicoDerm CQ®
- Store Brands (ex. Walmart’s “Equate” store brand or CVS Health store brand)
Dosing Information
Different types of products containing this active ingredient have different strengths. That’s why it is always important to read and follow the Drug Facts label. Most medicines warn against use of an active ingredient for longer than 7-10 days. Stop use and ask a doctor if symptoms persist.
A Note to Families:
While you might have seen media reports or social media posts on observational studies examining potential associations between acetaminophen use during pregnancy and neurodevelopmental outcomes (such as autism), it’s important to note that these studies do not demonstrate a causal relationship. In other words, there is currently no scientific evidence establishing that taking acetaminophen during pregnancy causes neurodevelopmental conditions.
Quick Facts:
1. Scientific and medical authorities around the world recognize acetaminophen as the only analgesic considered safe for use throughout an entire pregnancy when used according to the Drug Facts label.
2. There are no studies showing that acetaminophen use in children or during pregnancy causes autism.
3. Autism has many known risk factors, including genetics, but there is no clear, single cause.
4. Major health authorities like the FDA, CDC, and healthcare organizations such as the American College of Obstetricians and Gynecologists (ACOG) do not have warnings against acetaminophen use during pregnancy based on any known risk of autism and all recommend acetaminophen as the safest analgesic to use during pregnancy for short-term pain relief.
Frequently Asked Questions:
Why is acetaminophen used during pregnancy?
Scientific and medical authorities around the world recognize acetaminophen as the only pain reliever and fever reducer considered safe for use throughout an entire pregnancy when used according to the Drug Facts label, which specifically reminds pregnant women to always consult their healthcare provider before use. In fact, the American College of Obstetricians and Gynecologists (ACOG) states that: "Acetaminophen remains a safe, trusted option for pain relief during pregnancy.”
What is autism and does current science indicate what causes it?
Autism is a complex condition with many contributing factors, including genetic, environmental, and prenatal. Most scientists agree that the causes of autism are not simple, nor can they be traced back to one single factor like medication.
In fact, the Autism Science Foundation (ASF), a non-profit organization funding scientific autism research, specifically states that: it is disingenuous and misleading to boil autism's causes down to one simple thing," as there are hundreds of genes linked to autism in addition to other complex environmental factors.
Additionally, the most recent and rigorous research on this topic does not show a causal link to autism. The 2024 study published in the Journal of the American Medical Association (JAMA) analyzed nearly 2.5 million children using the gold-standard sibling comparison method, which controls for shared genetics and family environment, and found no association between acetaminophen use during pregnancy or infancy and neurodevelopmental issues such as autism.
In fact, the Autism Science Foundation (ASF), a non-profit organization funding scientific autism research, specifically states that: it is disingenuous and misleading to boil autism's causes down to one simple thing," as there are hundreds of genes linked to autism in addition to other complex environmental factors.
Additionally, the most recent and rigorous research on this topic does not show a causal link to autism. The 2024 study published in the Journal of the American Medical Association (JAMA) analyzed nearly 2.5 million children using the gold-standard sibling comparison method, which controls for shared genetics and family environment, and found no association between acetaminophen use during pregnancy or infancy and neurodevelopmental issues such as autism.
Why is it important to address fever during pregnancy?
High or long-lasting fevers can harm both the mother and baby and should be taken very seriously. Risks associated with leaving a fever untreated include birth defects, preterm labor, miscarriage, dehydration, or problems with the placenta, which significantly outweigh the risk of treatment.
What do regulatory authorities and major health organizations say?
The CDC and FDA agree acetaminophen is the safest analgesic to use during pregnancy for short-term pain relief, and recommend women to be cautious about overuse, which is why it is always recommended to follow the Drug Facts label and speak to your healthcare provider.
- CDC Yellow Book (Current as of April 23, 2025): “Acetaminophen remains the non-opioid analgesic of choice during pregnancy.”
- FDA’s Acetaminophen Page (Current as of August 14, 2025): “To date, FDA has not found clear evidence that appropriate use of acetaminophen during pregnancy causes adverse pregnancy, birth, neurobehavioral, or developmental outcomes.”
Additionally, the Society for Maternal-Fetal Health, a professional organization for obstetricians with subspecialty training in maternal-fetal medicine, stated on September 25, 2025 that it: "...continues to advise physicians and patients that acetaminophen is an appropriate medication to treat pain and fever during pregnancy…the weight of scientific evidence that acetaminophen use during pregnancy causes an increased risk for autism or ADHD is simply inconclusive…”
- CDC Yellow Book (Current as of April 23, 2025): “Acetaminophen remains the non-opioid analgesic of choice during pregnancy.”
- FDA’s Acetaminophen Page (Current as of August 14, 2025): “To date, FDA has not found clear evidence that appropriate use of acetaminophen during pregnancy causes adverse pregnancy, birth, neurobehavioral, or developmental outcomes.”
Additionally, the Society for Maternal-Fetal Health, a professional organization for obstetricians with subspecialty training in maternal-fetal medicine, stated on September 25, 2025 that it: "...continues to advise physicians and patients that acetaminophen is an appropriate medication to treat pain and fever during pregnancy…the weight of scientific evidence that acetaminophen use during pregnancy causes an increased risk for autism or ADHD is simply inconclusive…”
Is autism really on the rise?
When it comes to reports or claims that autism rates are higher than they were decades ago, the medical community’s ability to now better recognize and diagnose autism must be taken into consideration. Advances in medical knowledge, broader diagnostic criteria, and increased awareness among healthcare providers, educators, and parents mean that more cases are being identified today than in decades past. In other words, autism may not actually be “more common” than it once was; rather, we are better at detecting and recording it.
Is there a cure for autism?
No. There is no cure for autism. Autism is a complex neurodevelopmental condition influenced by many genetic and environmental factors. Treatments and supports focus on improving quality of life, communication, and daily functioning, not on “curing” autism.
What is leucovorin and why are there claims that it can “cure” autism?
Leucovorin (loo-ko-vor-in) is the prescription (Rx) form of folinic acid. It is officially approved by FDA for use in cancer therapy and as an antidote to certain medications. Some small studies have looked at leucovorinin individuals with cerebral folate deficiency (CFD). That’s why some families highlight it as promising. But it’s important to be clear: Leucovorin is not FDA-approved for autism or CFD. Its use for CFD is considered “off-label,” based on limited clinical evidence and physician judgement. On September 24, the FDA published a notice they intended to request that the drug sponsor submit an application to add information on CFD to the prescription drug label. Current research on its effectiveness in treating CFD is limited and preliminary. Calling it a “cure” for autism is misleading and not supported by robust, peer-reviewed evidence.
Safety Guide
Safety Guide
Nicotine and nicotine polacrilex are approved by the U.S. Food and Drug Administration (FDA) and are safe when used as directed. You should follow the appropriate product instructions and related quitting schedule that matches the amount of cigarettes you smoke per day.
Ask a healthcare provider before use if:
- You have completed the complete smoking cessation program and still feel the need to use a smoking cessation product.
- You are pregnant or breastfeeding.
- You had a recent heart attack or have heart disease or an irregular heartbeat.
- You have high blood pressure that is not controlled with medicines.
- You are using a non-nicotine stop smoking medicine.
- You are taking a prescription medicine for depression or asthma.
- You are under 18. OTC smoking cessation products are not available for sale to individuals under the age of 18.
- You are on a low-sodium diet. Some oral medicines may contain sodium.
Do not use if:
- You continue to smoke, chew tobacco, use snuff, or use a nicotine gum or other nicotine-containing product.
Stop use and ask a doctor if:
- You are using a patch and develop skin redness that does not go away after four days, your skin swells, or you get a rash.
- You experience mouth problems or severe sore throat while using a lozenge or gum.
- You have an irregular heartbeat or palpitations.
- You get symptoms of nicotine overdose such as nausea, vomiting, dizziness, weakness, and rapid heartbeat
- You take too much. Immediately contact a healthcare provider or the poison control national helpline at 800.222.1222.
What are the side effects of nicotine?
- Hiccups or belching
- Dizziness
- Upset stomach or nausea
- Throat or mouth soreness
- Common nicotine withdrawal symptoms can occur when you stop smoking and include dizziness, anxiety, depression, or trouble sleeping, among others. If any of these withdrawal symptoms or side effects persist or worsen, tell your doctor or pharmacist promptly.
