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Is it safe? · Pregnancy Smart

Is Theraflu safe during pregnancy?

Assigned clinical reviewerMatt Stahl· PharmDDraft · pending clinical reviewUpdated

What does the evidence say about theraflu during pregnancy?

  1. The Theraflu Multi-Symptom Severe Cold packet contains acetaminophen 500 mg, dextromethorphan HBr 20 mg, and phenylephrine HCl 10 mg, is labeled at no more than 6 packets in 24 hours, and warns that severe liver damage may occur above 4,000 mg of acetaminophen in 24 hours. 1
  2. The Nighttime version is a different formula: acetaminophen 650 mg, diphenhydramine HCl 25 mg, and phenylephrine HCl 10 mg per packet, capped at 5 packets in 24 hours. 2
  3. Studies of more than 1,500 pregnant people who took phenylephrine in the first trimester did not show an increased chance of birth defects, and taking phenylephrine could raise your blood pressure. 3
  4. At recommended dosages acetaminophen has not been shown to increase the chance of birth defects, and because it appears in many combination products, every label needs checking to avoid taking it twice. 4
  5. Dextromethorphan taken as directed for cough is not expected to increase the chance of birth defects, and some over-the-counter liquid products containing it also contain alcohol. 5

Is theraflu safe in each trimester?

  • First trimester. The decongestant is the first-trimester question. Studies of more than 1,500 pregnant people who took phenylephrine in the first trimester did not show an increased chance of birth defects, though one study found a slightly higher chance of minor differences of the eyes or ears.
  • Second trimester. This is where the acetaminophen arithmetic matters. Six Multi-Symptom packets a day is 3,000 mg of acetaminophen before you add anything else, against a 4,000 mg daily threshold above which severe liver damage may occur.
  • Third trimester. Multi-symptom powders are the hardest products to reason about late in pregnancy, because you are taking three or four drugs for two symptoms. Single-ingredient products let your provider approve exactly what you need.

What is in each Theraflu packet

ProductActive ingredients per packetLabeled adult directions
Theraflu Multi-Symptom Severe ColdAcetaminophen 500 mg, dextromethorphan HBr 20 mg, phenylephrine HCl 10 mgOne packet every 4 hours while symptoms persist, no more than 6 packets in 24 hours unless directed by a doctor
Theraflu Nighttime Severe Cold and CoughAcetaminophen 650 mg, diphenhydramine HCl 25 mg, phenylephrine HCl 10 mgOne packet every 4 hours while symptoms persist, no more than 5 packets in 24 hours unless directed by a doctor

Frequently asked questions

Which Theraflu is the one to ask about?

Whichever one is in your cupboard, because the formulas differ. Multi-Symptom Severe Cold is acetaminophen, dextromethorphan, and phenylephrine. Nighttime Severe Cold and Cough replaces the dextromethorphan with diphenhydramine and uses 650 mg of acetaminophen instead of 500 mg. Bring the box, or a photo of the panel, to the conversation.

Does Theraflu have phenylephrine?

Yes, 10 mg per packet in both the Multi-Symptom Severe Cold and Nighttime Severe Cold and Cough formulas. That is the decongestant, and it is also the ingredient the label flags for anyone with high blood pressure. MotherToBaby notes phenylephrine could raise your blood pressure.

Can I take Theraflu in the first trimester?

The first-trimester data on the individual ingredients is broadly reassuring: over 1,500 first-trimester phenylephrine exposures showed no increased chance of birth defects, and acetaminophen at recommended doses has not been shown to increase that chance either. The reason to check first is that you are taking three drugs at once, not one.

How much acetaminophen am I actually taking?

More than most people realize. Six Multi-Symptom packets in a day is 3,000 mg. Five Nighttime packets is 3,250 mg. The label warns that severe liver damage may occur above 4,000 mg in 24 hours from all sources combined, which is why a separate Tylenol on top is the mistake to avoid.

Is Theraflu safe while breastfeeding?

Both labels carry the same line: if pregnant or breast-feeding, ask a health professional before use. Acetaminophen appears in milk at low levels with rare effects in newborns, and dextromethorphan taken as directed short-term is not expected to cause problems for most breastfed infants. The decongestant is the piece to discuss.

References

  1. THERAFLU MULTI-SYMPTOM SEVERE COLD, acetaminophen, dextromethorphan HBr, phenylephrine HCl powder label

    NIH DailyMed · https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a4c56ca0-7785-404b-996d-137cc135f270

  2. THERAFLU NIGHTTIME SEVERE COLD AND COUGH, acetaminophen, diphenhydramine HCl, phenylephrine HCl powder label

    NIH DailyMed · https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5f7f6f70-0f36-4541-89f2-d953259cdb1e

  3. Phenylephrine: MotherToBaby Fact Sheet

    MotherToBaby · https://mothertobaby.org/fact-sheets/phenylephrine/

  4. Acetaminophen: MotherToBaby Fact Sheet

    MotherToBaby · https://mothertobaby.org/fact-sheets/acetaminophen/

  5. Dextromethorphan: MotherToBaby Fact Sheet

    MotherToBaby · https://mothertobaby.org/fact-sheets/dextromethorphan/

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.