Can You Take Tylenol Cold & Flu Severe At 8 Months Pregnant?

In our latest question and answer, the pharmacist discusses whether or not it is safe to take Tylenol Cold & Flu Severe while 8 Months Pregnant.

Question

Can I take Tylenol cold & flu severe at 8 Months pregnant?

Asked by Diamond Wade On May 16, 2018

Answered by
Medical Content Reviewed By PharmacistAnswers Staff

On May 20, 2018

Each caplet of Tylenol Cold + Flu Severe contains:

  • Acetaminophen 325 mg
  • Dextromethorphan 10 mg
  • Guaifenesin 200 mg
  • Phenylephrine 5 mg


The prescribing information does not offer much advice for pregnant women other than stating to ask a health professional before use. There are limited studies evaluating small numbers of pregnant women in regards to taking guaifenesin and phenylephrine specifically; however, the general recommendation is to avoid these medications in the first trimester, as this is the time when the majority of fetal development takes place.


During the third trimester, this medication can likely be used safely since the majority of the baby's development takes place during the first trimester and the likelihood of medications causing birth defects is much lower. However, it would still be worth a call to your doctor to ask, especially if you have any medical conditions. A doctor should be consulted before use if you have:

  • Heart disease
  • High blood pressure
  • Diabetes
  • Chronic lung diseases
  • Thyroid disease
  • Liver disease 


Pregnancy Trimesters

A pregnancy is considered full-term at 40 weeks, but consists of three trimesters.


The first trimester spans from 0-13 weeks and is the time when the baby undergoes the most development with formation of organs and body structure. During this period of time is when most defects occur, which is why it is crucial to seek advice of healthcare professionals when taking medications, as they may impact the formation of the baby.


The second trimester spans from 14-26 weeks, where much of the organ formation has already occurred, but bones and tissue continue to grow and some of the organs are not fully formed.


The third trimester spans from 27-40 weeks, and most of the organs are done forming.


Visit the Centers for Disease Control and Prevention's website on pregnancy to view other topics to consider during pregnancy.


Pregnancy Risk Categories for Medications

Although pregnancy risk categories are mostly being phased out and replaced with paragraph explanations of medication use in pregnancy and lactation, it is important to understand what they mean if you do see them.

  • Category A: controlled studies in pregnant women showed no evidence of risk to the fetus.
  • Category B: there have not been studies done in pregnant women, but animal reproduction studies have not shown fetal risk OR animal reproduction studies have shown adverse effects that were not seen in pregnant women.
  • Category C: there have not been studies done in pregnant women, but animal reproduction studies have shown adverse effects on the fetus OR no animal reproduction or pregnant women are available.
    • In this case, drugs should only be given if the benefits outweigh the risks.
  • Category D: studies have shown evidence of human fetal risk.
    • In this case, the benefits from use in pregnant women may outweigh the risks of the fetus (like in emergency situations).
  • Category X: studies in animal reproduction or pregnant women have shown evidence of fetal risk or abnormalities.
    • In this case, the risks outweigh the benefits of use in pregnant women and these medications should not be used while pregnant.


Over-the-Counter Decongestants, Cough Medications, and Acetaminophen

Decongestants

Studies are small and limited, but the safety of oral phenylephrine in pregnancy has not been established. Based on old, small studies, oral phenylephrine has the potential to cause some malformations. There are also some small studies on pseudoephedrine causing some birth defects, although these studies could be biased.


Further studies are necessary to fully determine the risk during pregnancy; however, decongestants should not be used during the first trimester of pregnancy since this is a pivotal time for fetal growth and development. During the second or third trimester, they could be used, but should only be used when necessary and as little as possible.


Summary For Decongestants

  • Oral phenylephrine
    • Pregnancy risk category: C
    • It does cross the placenta
    • Safety is not well-established and it should not be used during the first trimester
  • Pseudoephedrine
    • Pregnancy risk category: C
    • Unknown whether or not it crosses the placenta
    • There is a potential it causes birth defects and it should not be used during the first trimester

Cough Medications

Guaifenesin has very limited studies and no sufficient observations to determine whether or not it can or cannot be safely used during pregnancy. There is a very weak association with neural tube defects, though. Due to lack of evidence, it is not recommended for use during the first trimester of pregnancy.


Dextromethorphan animal reproductive studies with chickens found it to be harmful to chicken embryos; however, human studies have found no association with birth defects or malformations.


Summary For Cough Medications

  • Guaifenesin
    • Pregnancy category: C
    • Unknown whether or not it crosses the placenta
    • Safety is not well-established and it should not be used during the first trimester


  • Dextromethorphan
    • Pregnancy category: C
    • Unknown whether or not it crosses the placenta
    • Appears safe for use during pregnancy


Acetaminophen

Many studies of acetaminophen during pregnancy have been using combination products with other medications, so it is difficult to fully determine which medications are impacting the development of the baby. However, some suggest that acetaminophen alone does not increase fetal risk during pregnancy and it is safer to use acetaminophen over other medications like ibuprofen, naproxen, or aspirin. It is reported that at least two-thirds of women use acetaminophen during pregnancy.


Summary For Acetaminophen

  • Pregnancy category: B
  • It does cross the placenta
  • It is the pain management and fever reduction drug of choice during pregnancy


Tylenol Cold + Flu Severe Caplets

This medication can help with minor aches and pains, sore throat, congestion, and cough.

Warnings

  • Acetaminophen is contained in the product and the maximum daily dose of acetaminophen total is 4000 mg (10 caplets if just using this product), as it can cause liver damage in higher amounts.
    • Alcohol should be limited and if used in combination with other products containing acetaminophen, no more than 4000 mg should be taken within 24 hours.
  • Do not use with monoamine oxidase inhibitors (MAOIs) or within 2 weeks after stopping MAOIs.
    • Examples of MAOIs: rasagiline (Azilect), selegiline (Eldepryl, Zelapar), isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate).
  • Do not take the product if you've had a reaction to any of the components contained in the Tylenol Cold + Flu Severe.
  • Consult a doctor before use if you are taking warfarin, or if you have:
    • Heart disease
    • High blood pressure
    • Diabetes
    • Chronic lung diseases
    • Thyroid disease
    • Liver disease
  • Stop taking Tylenol Cold + Flu Severe and talk with a doctor if your symptoms last for more than 7 days, if fever gets worse after 3 days, if you develop symptoms of an allergic reaction, or if you experience nervousness, dizziness, or insomnia

About the Pharmacist

Dr. Anna Staudt Pharm.D

Dr. Anna Staudt graduated in 2017 with a Doctor of Pharmacy degree. She is completing a pharmacy fellowship focused on ambulatory care. Her current practice site is at a Federally Qualified Health Center (FQHC) where she deals with the underserved.

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