Baby Medicine Safety—and Which Medicines to Avoid
Medication Safety Guidelines and Tips for Babies
June 7, 2021

Medication Safety Guidelines and Tips for Babies

Medication Safety Guidelines and Tips for Babies .
Medication Safety Guidelines and Tips for Babies

Written Dr. Seran Kim, board-certified Emergency Physician

As a parent, the personal stress of a sick baby can feel like years taken off of your life. A common cold, fever, GI (gastrointestinal) “bug,” environmental allergies—these are all a rite of passage for most infants.

However, many common medications, even those that are over-the-counter (OTC), are not safe for babies. Deciphering which medications are safe for newborns can be both confusing and overwhelming. It is helpful to remember that newborns are not just “little adults.”

Administering some seemingly “safe” medications can actually cause great harm to babies, as they process and metabolize medications very differently. Fortunately, the Food and Drug Administration oversees and regulates OTC medications in the United States.

What are the medicines you shouldn’t your baby?

These are the top seven types of medications to avoid in infants:

1. Ibuprofen (Motrin)

Ibuprofen is an effective antipyretic (fever reducer) and analgesic (pain reliever). While great for fever and teething pain, ibuprofen should be avoided until your baby is at least 6 months old, unless otherwise directed by your doctor. Administering ibuprofen in infants less than 6 months old can lead to an increase in gastrointestinal side effects (such as vomiting, diarrhea and abdominal pain) as well as kidney impairment/renal failure.

Remember, a fever is defined as a rectal temperature >100.4 degrees Fahrenheit. If your infant is 3-6 months old with a fever, give Tylenol (acetaminophen) only. And for those infants under 3 months old with a fever, do not give ANY meds and call your doctor right away.

2. Aspirin (acetylsalicylic acid, salicylates)

The use of aspirin in children less than 18 years old should be completely avoided, since aspirin (and its derivatives) can increase the risk of Reye’s syndrome, a rare disorder that can cause significant brain swelling and liver damage. The exact mechanism is unknown, but Reye’s syndrome is usually triggered by a viral infection, such as the flu or chickenpox, followed by the use of aspirin.

Many other medications contain aspirin, such as Alka Seltzer, Pepto-Bismol and wintergreen oil. Be sure to check the labels so that you unwittingly do not give your infant or child aspirin-containing products.

3. Benzocaine

Benzocaine is the active ingredient found in many teething medications and gels, marketed to parents for the temporary relief of sore gums from teething in infants. Due to the lack of efficacy for teething and serious safety risks, the FDA is actually working to recall this medication for children less than 2 years of age. Benzocaine can cause a dangerous condition called methemoglobinemia, where the amount of oxygen carried through the blood is greatly reduced. This prevents tissues from receiving oxygen and can lead to cyanosis and even death.

The FDA also cautions the use of homeopathic teething tablets, like Hyland’s, so always consult with your physician before considering any homeopathic medications.

4. OTC cough and cold products, including cough syrup and expectorants, containing dextromethorphan or guaifenesin (such as Robitussin, NyQuil, Triaminic, Theraflu)

The common cold in babies can give parents high anxiety, but most cold symptoms go away on their own without any medicine. But colds remain one of the top reasons parents bring their children in to see their pediatrician.

It is important to know that the FDA does not recommend any OTC medicines for cough or cold symptoms in children less than 2 years old. These include expectorants (for loosening mucus so that it can be coughed up) and antitussives (for quieting coughs). The label may also include “nasal decongestants,” “cough suppressants” and “antihistamines”—all of which should also be avoided in children less than 2 years of age.

Manufacturers are now voluntarily relabeling packaging to warn for use in children under 4 years of age. Ingestion of these medications can lead to convulsions, rapid heart rates, decreased levels of consciousness and even death.

Safer alternatives for relieving cold symptoms include a cool mist humidifier and/or nasal suctioning with saline.

5. Antihistamines, such as diphenhydramine (Benadryl), loratadine (Claritin), cetirizine (Zyrtec), and fexofenadine (Allegra)

Diphenhydramine, better known as Benadryl, should never be given to infants for cold or cough symptoms, for similar reasons as to why we avoid cough syrup and expectorants. Infant ingestion of Benadryl can lead to convulsions, rapid heart rates, trouble breathing and even death. Benadryl can sometimes be used for allergy symptoms in infants, but this is under the direct supervision of a physician. And Benadryl should never be administered for off-label uses, such as helping children fall asleep for a big car or plane ride or even getting them to sleep for a normal night.

First-generation antihistamines, such as Benadryl, are not very selective, and interfere with many pathways in the body, hence the broad range of side effects. Newer, second-generation antihistamines offer the same benefit in counteracting histamine but are much more selective in their mechanism of action. These second-generation antihistamines include loratadine (Claritin), cetirizine (Zyrtec), and fexofenadine (Allegra). However, even these should not be used in children less than 2 years old, unless directed by a physician.

6. Decongestants, containing pseudoephedrine or phenylephrine (such as Dimetapp, Sudafed or Mucinex)

Not only does the data show that the use of decongestants in babies is no better than a placebo, but these medications are “sympathomimetics,” which causes blood vessels to constrict and can lead to convulsions, a rapid heart rate and even death. Therefore, decongestants should be avoided in all babies under the age of two years old, and quite frankly, should not be administered in any child under 12 years of age.

So what to do about that stuffy nose? Usually, the culprit is the common cold, which is due to a virus. Antibiotics do not have any effect on viral infections. Most colds go away on their own, but there are a variety of home remedies that have proven more effective than any decongestant, including proper nasal suctioning with saline, a cool mist humidifier and steam inhalation (such as from the hot shower).

7. Anti-diarrheal medications, containing bismuth or loperamide (such as Pepto-Bismol, Kayopectate and Immodium)

While diarrhea can be alarming (and overwhelmingly messy), it is important to note that it can lead to dehydration in infants. Regardless, babies should never be given any anti-diarrheal medication for acute gastroenteritis (also known as the stomach flu), as these medications can cause lethargy and ileus (intestinal obstruction). Studies have also found that they have no benefits over placebo, even in older children, so should only be used under the close supervision of a physician.

Medication tips for babies

  • Dose carefully, with the package-included dropper or measuring device only.
  • Dosing based on the child’s weight, rather than age, is always recommended, since baby sizes vary. Be sure to know your baby’s most recent weight.
  • Always use infant formulations. Don’t be tempted to give baby “smaller doses” of adult medication.
  • Check expiration dates. Expired meds can lose potency over time, or chemically break down into dangerous compounds. Dispose of expired medications properly. Often, your local police department will have a drug collection program, as do some pharmacies.

As a safe rule, always consult your doctor before giving any infant medication, even if it is easily accessible in the drug store aisle. With all of the things to remember as a new parent, discerning which medications to take or avoid should not be one of them. Do not hesitate to ask. Your doctors are here for you.

Disclaimer: The medical information provided does not substitute for medical advice and is for educational purposes only.

Factually reviewed by Dr. Seran Kim, board-certified Emergency Physician, on June 7, 2021.


Dr. Seran Kim is a board-certified Emergency Physician, cancer survivor and mom to three rambunctious boys, and she’s one of the doctors who helped develop the Babylist First Aid Kit. When not working, she can be found hiking, reading or embarrassing her kids with her hip-hop dancing. She has a weakness for milk chocolate and succulent plants that don’t need regular watering. She cannot live without GooGone and her power drill. She is adamant about helmets and seatbelts—and coffee. She believes the key to parenting survival is surrounding yourself with other families and raising kids as a village.

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