Childrens Fever Reliever
FDA Label NDC 57955-0159

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by King Bio Inc. for the product Childrens Fever Reliever (NDC 57955-0159). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding warnings, otc - keep out of reach of children, dosage and administration, hpus active ingredients, purpos, inactive ingredients, indications and usage, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Warnings

  • Stop use and ask your doctor if symptoms persist or worsen.
  • If pregnant or breast-feeding, take only on advice of a healthcare professional.
  • Keep out of reach of children.
  • Tamper resistant for your protection. Use only if safety seal is intact.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Dosage And Administration

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth.
  • Adults: 3 sprays 3 times per day.
  • Children 2-12 years: 2 sprays 3 times per day.
  • Use additionally as needed, up to 6 times per day.

Hpus Active Ingredients

Aceticum acidum, Aconitum napellus, Aesculus hippocastanum, Agaricus muscarius, Baptisia tinctoria, Belladonna, Bryonia, Chamomilla, Eupatorium perfoliatum, Ferrum phosphoricum, Gelsemium sempervirens, Pulsatilla, Rhus toxicodendron, Sambucus nigra, Sulphur, Veratrum Viride. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, LM1, LM2, LM3 potencies.

Purpos

Uses for fast relief of symptoms:

  • fever
  • sweats
  • chills
  • aches
  • nausea
  • lethargy
  • irritability
  • oversensitivity
  • restlessness
  • If fever lasts for more than three days, is accompanied by a rash or persistent headache, or if new symptoms occur, consult a doctor.

Inactive Ingredients

Bio-Energetically Enhanced™ pure water base, Citric acid and Potassium sorbate.

Indications And Usage

Uses for fast relief of symptoms: fever, sweats, chills, aches, nausea, lethargy, irritability, oversensitivity, restlessness. If fever lasts for more than three days, is accompanied by a rash or persistent headache, or if new symptoms occur, consult a doctor.

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