What are the recommendations for pediatric cough syrup (over-the-counter (OTC) medication)?

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Last updated: May 20, 2025View editorial policy

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From the Guidelines

Pediatric cough syrup should not be used in children under 4 years old due to limited effectiveness and potential side effects, and for children 4-6 years, use only under medical supervision. For children over 6 years, common over-the-counter options include dextromethorphan (for dry coughs) and guaifenesin (for productive coughs) 1. Always use the measuring device provided with the medication and follow age-appropriate dosing on the package. Never use adult formulations for children.

Key Considerations

  • Honey (1 teaspoon) can be an effective natural remedy for children over 1 year old, but for infants under 1 year, avoid all cough syrups and honey due to safety concerns 1.
  • Non-medication approaches like maintaining hydration, using a cool-mist humidifier, and saline nasal drops can help manage symptoms.
  • Contact a healthcare provider if the cough persists beyond 7 days, is accompanied by high fever, difficulty breathing, or if the child is under 3 months old with any cough.

Diagnosis and Management

  • For children with chronic cough, a systematic approach should be taken to determine the cause of the cough, and management should be based on the etiology of the cough 1.
  • A chest radiograph and, when age appropriate, spirometry (pre and post β2 agonist) should be undertaken 1.
  • For children with chronic wet or productive cough unrelated to an underlying disease and without any specific cough pointers, antibiotics targeted to common respiratory bacteria may be recommended 1.

From the FDA Drug Label

DIRECTIONS Follow dosage below or use as directed by a physician. do not take more than 6 doses in any 24-hour period. age dose adults and children 12 years and over10 to 20 mL (2 to 4 teaspoonfuls) every 4 hours children 6 years to under 12 years5 to 10 mL (1 to 2 teaspoonfuls) every 4 hours children 2 to under 6 years of age2.5 to 5 mL (½ to 1 teaspoonful) every 4 hours children under 2 years of ageconsult a physician Directions • shake bottle well before use • measure only with dosing cup provided • do not use dosing cup with other products • dose as follows or as directed by doctor adults and children 12 years of age and over 10 mL every 12 hours, not to exceed 20 mL in 24 hours children 6 to under 12 years of age 5 mL every 12 hours, not to exceed 10 mL in 24 hours children 4 to under 6 years of age 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours children under 4 years of age do not use The recommended dosage for pediatric use of cough syrup is as follows:

  • For guaifenesin (PO) 2:
    • Children 6 to under 12 years: 5 to 10 mL (1 to 2 teaspoonfuls) every 4 hours
    • Children 2 to under 6 years: 2.5 to 5 mL (½ to 1 teaspoonful) every 4 hours
    • Children under 2 years: consult a physician
  • For dextromethorphan (PO) 3:
    • Children 6 to under 12 years: 5 mL every 12 hours, not to exceed 10 mL in 24 hours
    • Children 4 to under 6 years: 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours
    • Children under 4 years: do not use

From the Research

Cough Syrup for Pediatrics

  • Cough due to upper respiratory tract infections (URIs) is a common complaint in children, but there is limited evidence to support the use of therapeutic agents to treat acute cough due to URI 4.
  • Published research does not support the efficacy of narcotics (codeine, hydrocodone) and US Food and Drug Administration (FDA)-approved over-the-counter (OTC) oral antitussives and expectorants (dextromethorphan, diphenhydramine, chlophedianol, and guaifenesin) for URI-associated pediatric cough 4.
  • Alternatively, honey and topically applied vapor rubs may be effective antitussives for pediatric cough 4, 5.
  • A clinical trial study found that honey was more effective than dextromethorphan (DM) and diphenhydramine (DPH) in alleviating URIs-induced cough in children 5.

Treatment Options

  • Dextromethorphan (DM) may modestly decrease cough in adults, but not in children 6.
  • Antihistamines, antihistamine-decongestant combinations, and guaifenesin do not provide greater relief than placebo in adults or children 6.
  • Honey may modestly decrease frequency and severity of cough compared with DM or no treatment in children 6, 5.
  • Many remedies for cough are self-prescribed, but significant evidence of their efficacy and safety is missing in pediatric populations 7.

Safety and Efficacy

  • Lack of clear indications for dosing and treatment duration, the number of available drugs, and multiple caregivers administering medication to children have been considered contributors to an increased risk of inappropriate prescribing, accidental overdosing, and adverse events 7.
  • A review of the safety and efficacy of available cough remedies for the pediatric age group found that some treatments have been shown to be no more effective than placebo 7.

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.

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