Cough drops

THE SAFETY OF COUGH DROPS DURING PREGNANCY OR BREASTFEEDING

The information provided below is for readers based in the United States of America. Readers outside of the United States of America should seek the information from local sources.

THIS MEDICATION CAN CAUSE HARM TO YOUR BABY:
There are a lack of human studies evaluating the safety of menthol in pregnancy or breastfeeding. Menthol is expected to pose a low risk of harm to the developing baby. The recommended maximum human daily dose of menthol is 4.0 mg/kg. Cough drops may contain other active or inactive ingredients that have limited available evidence to support their safety while pregnant or breastfeeding. It is important to talk to your doctor before using over-the-counter cough drops during pregnancy.

What are cough drops?

Cough drops are used to soothe cough and sore throat. Some cough drops are non-medicated, containing pectin and fruit flavoring to soothe and lubricate the throat. Medicated cough drops often contain menthol, a derivative of peppermint, and a mixture of herbs or fruit flavorings. Cough drops are available as drops or lozenges. Cough drops are available over-the-counter and can be purchased without a prescription. 

What are cough drops used to treat?

Cough drops are used to manage symptoms of cough and sore throat in children (recommended age for use may depend on the product), adolescents, and/or adults. Cough and sore throat can be caused by many different factors including the common cold or flu. Coughing caused by the common cold or flu can cause the throat to become irritated and inflamed. Cough drops are used to decrease coughing and to soothe an irritated throat using medicinal and non-medicinal ingredients.

How do cough drops work?

Menthol works by stimulating cooling receptors in the body, which create a cooling sensation in the throat when used in a cough drop. Some cough drops contain oral anesthetics that work by inhibiting pain nerve signals in the mouth. Some cough drops can also contain dextromethorphan, a cough suppressant that works by inhibiting the cough center in the brain and decreasing the need to cough. 

If I am using cough drops, can they harm my baby?

Menthol is a common ingredient in over-the-counter cough drops. There are no human studies evaluating the safety of menthol in human pregnancies. Despite the lack of evidence, the overall risk harm to the developing baby with menthol exposure is expected to be minimal. The amount of menthol present in most cough drops is small. 

Evidence from animal studies with menthol:

When menthol was given to pregnant rats, mice, hamsters, and rabbits at doses up to 106 times the recommended daily human intake, no birth defects were reported. 

Evidence for the risks of menthol/cough drops in human babies:

Active and inactive ingredients (can vary by product) in common, over-the-counter cough drops are noted below – information is taken from manufacturer websites:

Active ingredients: menthol

Inactive ingredients: ascorbic acid, citric acid, corn syrup, FD&C yellow no. 5, flavors, honey, sodium acetate, sodium chloride, soybean oil, sucrose, water

Active ingredients: menthol

Inactive ingredients: capscium, dextrin, eucalyptus oil, natural licorice, sugar, tragacanth

Active ingredients: menthol

Inactive ingredients: color (caramel), extract of ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), peppermint oil, starch syrup, sugar

  • Halls Cherry Flavor Cough Drops

Active ingredients: menthol

Inactive ingredients: Eucalyptus oil, FD&C blue 2, FD&C red 40, flavors, glucose syrup, soy lecithin, sucralose, sucrose, water

Active ingredients: Dyclonine hydrochloride (oral anesthetic), menthol

Inactive ingredients: Acesulfame Potassium, Ascorbic Acid, Cherry Flavor, Citric Acid, Corn Syrup, FD&C Red #40, Propylene Glycol, Sodium Ascorbate, Sucrose, Tartaric Acid, Water, Zinc Gluconate

  • Cepacol Extra Strength Sore Throat and Cough

Active ingredients: Benzocaine (oral anesthetic), dextromethorphan (cough suppressant), menthol

Inactive ingredients: D&C Yellow 10, Fd&C Yellow 6, Flavors, Isomalt, Maltitol, Propylene Glycol, Purified Water, Sodium Bicarbonate, Sucralose

Active ingredients: Honey

Inactive ingredients: menthol, flavoring

Common inactive ingredients in over-the-counter cough drops: benzocaine, dyclonine hydrochloride, echinacea, eucalyptus, honey, zinc, capscium, dextromethorphan

  • Zinc: safe in pregnant women in daily maximum doses of 40 mg per day (higher doses can increase the risk of premature birth)
  • Echinacea: safe for use for a maximum of 5 to 7 days, but not recommended during pregnancy due to limited evidence on safety 
  • Eucalyptus oil: not recommended during pregnancy due to limited evidence on safety
  • Capscium: no available information on safety during pregnancy
  • Honey: pasteurized honey should be safe during pregnancy 
  • Benzocaine: not recommended during pregnancy due to limited evidence on safety 
  • Dyclonine hydrochloride: limited safety information in pregnant women; should only be used if the maternal conditions justifies its use
  • Dextromethorphan: safe in pregnant women; liquid dextromethorphan in ethanol is not recommended in pregnant women

According to the Food and Agriculture Organization of the United Nations and the World Health Organization, the estimated amount of menthol that is safe for humans to consume daily is up to 4.0 mg/kg. The average person is 70 kg (154 lbs) so the maximum daily amount of menthol for a 70 kg person would be 280 mg.

The menthol concentrations in common, over-the-counter cough drops are noted below – information is taken from manufacturer websites:

Bottom line: While there are no available human studies evaluating the safety of menthol during pregnancy, menthol is expected to pose a low risk of harm to the developing baby. The recommended maximum human daily dose of menthol is 4.0 mg/kg. Cough drops may contain other active or inactive ingredients that have limited available evidence to support their safety. It is important to talk to your doctor before using over-the-counter cough drops during pregnancy.

If I am using cough drops and become pregnant, what should I do?

If you are using cough drops and become pregnant, you should contact your doctor immediately. Your doctor will determine if your medication is medically necessary, or if it should be discontinued until after the birth of your baby.

If I am using cough drops, can I safely breastfeed
my baby?

There is very little data available on the effects of menthol on the breastfed baby. Small amounts of menthol are expected to pass into breast milk. Topical menthol has been used to treat pain associated with cracked nipples. If menthol is used on the breasts, it should be wiped off before nursing. 

Bottom line: There is no evidence on the safety of menthol exposure in nursing infants. Small amounts of menthol are expected to pass into breast milk.

If I am using cough drops, will it be more difficult to get pregnant?

There are no available studies in human on the effects of menthol on fertility. Animal studies suggest menthol does not harm male or female fertility. 
 

If I am using cough drops, what should I know?

There are a lack of human studies evaluating the safety of menthol in pregnancy or breastfeeding a baby. Menthol is expected to pose a low risk of harm to the developing baby. The recommended maximum human daily dose of menthol is 4.0 mg/kg. Cough drops may contain other active or inactive ingredients that have limited available evidence to support their safety. Ingredients such as echinacea, eucalyptus oil, dyclonine hydrochloride, and benzocaine are not recommended during pregnancy. It is important to talk to your doctor before using over-the-counter cough drops during pregnancy.

If I am taking any medication, what should I know?

This report provides a summary of available information about the use of cough drops during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.

You may find Pregistry's expert report about cough here, and reports about various other respiratory disorders as well as the individual medications used to treat respiratory disorders here.   Additional information can also be found in the resources below. 

For more information about cough drops. during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following links:

DrugBank: Menthol.

U.S. News & World Report: Cough Lozenges.

The Bump: Is Honey Safe During Pregnancy?

Mayo Clinic: Pregnancy Nutrition: Foods to Avoid During Pregnancy.

Read the whole report
Last Updated: 27-04-2019
General information

It is very common for women to worry about having a miscarriage or giving birth to a child with a birth defect while they are pregnant. Many decisions that women make about their health during pregnancy are made with these concerns in mind.

For many women these concerns are very real. As many as 1 in 5 pregnancies end in a miscarriage, and 1 in 33 babies are born with a birth defect. These rates are considered the background population risk, which means they do not take into consideration anything about the health of the mom, the medications she is taking, or the family history of the mom or the baby’s dad. A number of different things can increase these risks, including taking certain medications during pregnancy.

It is known that most medications, including over-the-counter medications, taken during pregnancy do get passed on to the baby. Fortunately, most medicines are not harmful to the baby and can be safely taken during pregnancy. But there are some that are known to be harmful to a baby’s normal development and growth, especially when they are taken during certain times of the pregnancy. Because of this, it is important to talk with your doctor or midwife about any medications you are taking, ideally before you even try to get pregnant.

If a doctor other than the one caring for your pregnancy recommends that you start a new medicine while you are pregnant, it is important that you let them know you are pregnant.

If you do need to take a new medication while pregnant, it is important to discuss the possible risks the medicine may pose on your pregnancy with your doctor or midwife. They can help you understand the benefits and the risks of taking the medicine.

Ultimately, the decision to start, stop, or change medications during pregnancy is up to you to make, along with input from your doctor or midwife. If you do take medications during pregnancy, be sure to keep track of all the medications you are taking.