Is 12-hour pseudoephedrine (Sudafed) safe for a 13-year-old?

Medical Advisory BoardAll articles are reviewed for accuracy by our Medical Advisory Board
Article Review Status
Submitted
Under Review
Approved

Last updated: April 18, 2025 • View editorial policy

From the Guidelines

Sudafed (pseudoephedrine) 12-hour formulation can be used in a 13-year-old, but it's best to consult their pediatrician or healthcare provider first to discuss potential risks and benefits, as well as proper dosage and administration 1, 2.

Key Considerations

  • The medication works by narrowing blood vessels in the nasal passages to reduce congestion, but can cause side effects like nervousness, dizziness, or trouble sleeping.
  • Oral decongestants, such as pseudoephedrine, are effective at relieving nasal congestion in patients with allergic and nonallergic rhinitis, but can result in side effects such as insomnia, loss of appetite, irritability, and palpitations 2.
  • The extended-release 12-hour formulation contains higher amounts of medication and is typically only approved for those 12 and older.

Alternative Options

  • Saline nasal sprays
  • Proper hydration
  • Using a humidifier ### Important Notes
  • Pseudoephedrine-containing products are kept behind the pharmacy counter and require ID for purchase due to restrictions on this ingredient.
  • Patients receiving oral decongestants should be followed for changes in blood pressure, as elevation of blood pressure after taking an oral decongestant is very rarely noted in normotensive patients and only occasionally in patients with controlled hypertension 1.

From the FDA Drug Label

Directions adults and children 12 years and over • take 2 tablets every 4 to 6 hours The 12-hour Sudafed is okay for a 13-year-old since the drug label indicates that it can be used for children 12 years and over 3.

From the Research

Pseudoephedrine Usage for a 13-Year-Old

  • The provided studies do not directly address the safety of 12-hour Sudafed for a 13-year-old.
  • However, a study on pseudoephedrine 4 found that a 60 mg dose is safe and effective for treating nasal congestion associated with the common cold in patients with a mean age of 20 years.
  • There is no specific information on the safety of pseudoephedrine for 13-year-olds, but it is known that pseudoephedrine is a commonly used oral decongestant 4.
  • Another study discusses the benefits and risks of pseudoephedrine 5, but does not provide age-specific guidelines for its use.
  • The other studies provided 6, 7, 8 are unrelated to the use of pseudoephedrine and focus on physical activity and its effects on adolescents.

Considerations for Adolescent Health

  • Regular exercise is associated with improved cognitive function, brain structure, and academic performance in adolescents 7.
  • However, compulsive exercise can be a risk factor for eating disorders in adolescents 8.
  • The Physical Activity Guidelines for Americans recommend at least 60 minutes of moderate-to-vigorous physical activity daily for children and adolescents aged 6-17 years 6.

Pseudoephedrine Safety and Efficacy

  • Pseudoephedrine has been shown to be a safe and effective treatment for nasal congestion associated with upper respiratory tract infections in adults 4.
  • The substance has central nervous system stimulant properties and can be used for non-medical purposes, such as an appetite reducer or a doping agent 5.

References

Guideline

the diagnosis and management of rhinitis: an updated practice parameter.

Journal of Allergy and Clinical Immunology, 2008

Guideline

the diagnosis and management of rhinitis: an updated practice parameter.

Journal of Allergy and Clinical Immunology, 2008

Research

Pseudoephedrine-Benefits and Risks.

International journal of molecular sciences, 2021

Research

Exercise, cognition, and the adolescent brain.

Birth defects research, 2017

Research

Exercise Caution: Questions to Ask Adolescents Who May Exercise Too Hard.

International journal of environmental research and public health, 2018

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.