What is the appropriate dosing and safety information for Ninjacof (chlophedianol 12.5 mg + pyrilamine 12.5 mg per 5 mL) for adults, children, and infants?

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Last updated: August 12, 2026 • View editorial policy

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Ninjacof Dosing and Safety Information

Ninjacof should be dosed at 2 teaspoonfuls (10 mL) every 6-8 hours for adults and children ≥12 years (maximum 8 teaspoonfuls/24 hours), 1 teaspoonful (5 mL) every 6-8 hours for children 6 to <12 years (maximum 4 teaspoonfuls/24 hours), and requires physician consultation for children under 6 years of age. 1

FDA-Approved Dosing by Age Group

Adults and Children ≥12 Years

  • Dose: 2 teaspoonfuls (10 mL) every 6-8 hours
  • Maximum: 8 teaspoonfuls in 24 hours
  • Active ingredients per dose: Chlophedianol 25 mg + Pyrilamine 25 mg 1

Children 6 to <12 Years

  • Dose: 1 teaspoonful (5 mL) every 6-8 hours
  • Maximum: 4 teaspoonfuls in 24 hours
  • Active ingredients per dose: Chlophedianol 12.5 mg + Pyrilamine 12.5 mg 1

Children <6 Years

  • Recommendation: Consult a physician before use 1
  • This age restriction reflects the general lack of safety and efficacy data for cough/cold medications in young children, as well as concerns about appropriate dosing in this population where drug elimination pathways may still be maturing 2

Safety Considerations

Pyrilamine-Specific Warnings

Cardiac effects: Pyrilamine, a first-generation antihistamine, has been associated with QT interval prolongation in overdose situations 3. While generally considered safe at therapeutic doses, caution is warranted when combining with other QT-prolonging medications (macrolides, antifungals, antipsychotics, other antihistamines) 3.

Common antihistamine side effects to monitor:

  • Sedation (particularly relevant as a first-generation antihistamine)
  • Mucosal dryness
  • Urinary retention 4

Overdose Management

In case of overdose, immediately contact Poison Control or seek emergency medical care 1. The combination of a cough suppressant (chlophedianol) and antihistamine (pyrilamine) requires monitoring for:

  • Central nervous system depression
  • Cardiac rhythm abnormalities (particularly QT prolongation)
  • Anticholinergic effects

Contraindications and Precautions

While the FDA label does not specify absolute contraindications beyond age restrictions, exercise caution in:

  • Patients taking other CNS depressants or sedating medications
  • Patients with cardiac conduction abnormalities
  • Patients on medications that prolong QT interval
  • Patients with urinary retention or narrow-angle glaucoma (typical antihistamine precautions)

Clinical Pearls

Do not exceed recommended dosages - the formulation contains fixed-dose combinations that cannot be adjusted independently 1. The 6-8 hour dosing interval provides flexibility but should not result in exceeding maximum daily doses.

Infants require special consideration: The lack of approval for children under 6 years reflects both the immature drug elimination pathways in this age group and the limited evidence for efficacy and safety of cough/cold preparations in young children 2. Physician consultation is mandatory for this population 1.

References

4
Guideline

clinical practice guideline: allergic rhinitis.

Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery, 2015

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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.