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Treating Cough & Cold Symptoms in Children Under 2-Years-Old. By Our Student Pharmacist, Elaine Sim.

Watching a baby struggle to breath through a congested nose or feeling a tiny body hot to the touch from a fever can make any parent worry.

During my pharmacy internship at Nationwide Children’s Hospital, many parents inquired about appropriate over-the-counter (OTC) cough and cold products for infants and young toddlers. They typically asked whether or not they could give their children decongestants, antihistamines, cough suppressants, and cough expectorants.

Oftentimes, I told them that the Food and Drug Administration (FDA) strongly recommends against using OTC cough and cold medications in children less than two-years-old due to life-threatening side effects. In fact, many manufacturers even set the age cut-off on their labels at four-years-old. According to the FDA’s adverse event reporting program, MedWatch, some cold and cough products have been associated with death, seizures, rapid heart rate, and decreased levels of consciousness in babies.

As you peruse the cough and cold aisle in pharmacies, you will see that many products are only indicated in children two years and older. So what can you do for a four month old or one-year-old child?

There are a few OTC products that may be used in children less than two-years-old. These products include pain relievers/fever reducers and saline nose drops/sprays. There are no OTC products that relieve cough for this age group, though coughing is less common in babies.

Below you will find a list of appropriate home remedies and OTC products.

Cool mist humidifier: Cool mist can help decrease congestion in the nasal passages. Try to avoid warm mist as it can cause swelling in the nasal passages and make breathing more difficult. Warm humidifiers can also cause burns on delicate skin.

cool mist humidifier

Saline nose drops or sprays: Saline solutions keep nasal passages moist and decrease congestion. Avoid nasal drops that say “decongestant” on them as these contain phenylephrine and should not be used in children less than two-years-old.

saline drops

Hydration: It is important for children to drink plenty of fluids, mainly water.

water cup

Nasal suctioning with bulb syringe: Bulb syringes may be used to suction out mucus. Applying three to four saline drops in each nostril before suctioning can help thin out mucus that is too thick to suction. Limit suctioning to four times a day to avoid nose irritation.

bulb syringe

Pain relievers/fever reducers: Consult your child’s pediatrician before use.

Infant acetaminophen (Tylenol) or ibuprofen (Advil) are approved in babies less than two years and are both dosed by weight. The concentration of Tylenol is 160 mg per 5 mL and the concentration of Advil is 50 mg per 1.25 mL. You can use the weight-based dosing on the package insert of the products or you can ask your pharmacist for more guidance.

We recommend a therapeutic Tylenol dose of 10 to 15 mg/kg/dose and Advil dose of 5 to 10 mg/kg. For younger children, it is a good idea to space Tylenol doses every six hours and Advil every eight hours.

Note: There is a children’s chewable tablet that comes as a 160 mg dose. This should not be used in children less than two.

infant tylenol infant advil

Homeopathic products are not FDA approved and should be used with caution as some may contain active ingredients that actually exceed the amount stated on the product label.

Vicks BabyRub is an aromatic ointment that has been used to soothe fussy babies, but will not help with congestion or cough. Unlike both children’s and adult’s VapoRub, BabyRub does not contain menthol and camphor or any other active drug ingredient. Instead, BabyRub consists of eucalyptus, rosemary, lavender, aloe vera, petrolatum, coconut oil, and mineral oil. BabyRub may be massaged onto the chest, neck, back, and soles of the feet of babies above the age of three months. It should not be applied anywhere on the face, near the mouth, in the nostrils, or on broken skin. It is also important to avoid contact with eyes.

I have met many parents who use this product and report minimal side effects. While this product is relatively safe, parents should watch out for accidental ingestion (e.g. when baby places foot in mouth), skin irritation, and applying to hot skin as this can increase absorption.

BabyRub

Things to Avoid:

DO NOT GIVE HONEY. While honey is used to soothe a sore throat and relieve a cough in older children and adults, it should NOT be used in children less than one-year-old because of the risk of infant botulism. Infant botulism is caused by a toxin produced by Clostridium botulinum bacteria found in soil and dust. The bacteria is also known to contaminate honey and some corn syrups.

Symptoms of infant botulism include:

  • muscle weakness
  • poor feeding
  • weak cry
  • constipation
  • “floppiness” or decreased muscle tone

As kids get older, their digestive system will mature and eliminate the bacteria from the body before it causes harm.

DO NOT GIVE OTC PRODUCTS THAT CONTAIN ALCOHOL. Some OTC products for young children ages 6-12 can contain up to 5% alcohol. Alcohol can impair the ability of infants to breath on their own and can also increase the risk of seizures.

DO NOT GIVE OTC PRODUCTS THAT CONTAIN ASPIRIN. In young children, aspirin is associated with Reye’s Syndrome, a life-threatening condition characterized by brain and liver damage.

When to Call the Pediatrician:

  • OTC products do not relieve symptoms or symptoms worsen after 24 hours.
  • Your child is having a hard time breathing and makes wheezing or grunting noises.
  • Your child has ear pain and pulls their ears or rolls their head from side to side.
  • Your child has difficulty feeding or refuses feeding.
  • Your child appears very pale or gray/blue.
  • Your child is not “acting right.”
  • Less than 2 months old: rectal temperature above 100.4 °F
  • Less than 2 years old: rectal temperature above 102 °F or a forehead, armpit, or ear temperature above 103 °F

Note: Rectal temperatures are preferred in infants and toddlers. Oral temperatures are not recommended in children less than four-years-old. It is hard for younger children to keep the thermometer fully under their tongue for long enough. Forehead strips change color to show temperature, but are the least accurate method.

Always carefully read product labels to ensure a medication is safe to use in your child. If you have any doubts or questions, never hesitate to ask your pharmacist or doctor for help!

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