Headache Relief
FDA Label NDC 57955-5153

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 Headache Relief (NDC 57955-5153). 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 active ingredients, warnings, purposes, indications and usage, otc - keep out of reach of children, dosage and administration, inactive ingredients, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Official HPUS: Belladonna, Bryonia, Capsicum annuum, Chininum arsenicosum, Coffea cruda, Gelsemium sempervirens, Glonoinum, Ignatia amara, Kali bichromicum, Lycopodium clavatum, Natrum muriaticum, Nux vomica, Sanguinaria canadensis, Spigelia anthelmia, Sulphur.

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Warnings

If symptoms persist or worsen, consult a physician.  If pregnant or nursing, take only on advice of healthcare professional.  Keep out of reach of children.

Other: Tamper resistant for your protection.  Use only if safety seal is intact.

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Purposes

Uses for temporary relief of headache pain:

  • throbbing / splitting
  • tight / bursting
  • sinus / congestive
  • migraine / occipital
  • dull / sick
  • band feeling around head
  • morning headache
  • sun headache
    • Reference image headacherelief.jpg

Indications And Usage

Uses for temporary relief of headache pain: throbbing/splitting, tight/bursting, sinus/congestive, migraine/occipital, dull/sick, band feeling around head, morning headache, sun headache

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Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

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Dosage And Administration

Directions: Initially, depress pump until primed.  Hold close to mouth and spray directly into mouth.  Use 3 times daily.  Use additionally as needed.

Adult Dose - 3 pump sprays

Children (2-12 years) - 2 pump sprays

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Inactive Ingredients

Equal volumes of each ingredient in a Bio-Energetically Enhanced pure water base: 10X, 30X, and LM1 potencies.

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Package Label.Principal Display Panel

Image Of Label (Headacherelief)

Image Of Label (Headacherelief)

King Bio, Inc.

3 Westside Dr

Asheville, NC 28806

Questions? Call 800.543.3245

www.kingbio.com




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