Headache Relief
FDA Label NDC 47242-0081

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Homeostasis Laboratories, Inc. for the product Headache Relief (NDC 47242-0081). 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 otc - active ingredient, uses, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active IngredientsPurpose
Belladonna 30C, HPUSRelieves throbbing pains
Bryonia 30C, HPUSRelieves sharp pains
Gelsemium sempervirens 30C, HPUSRelieves heaviness in the head
Sanguinaria canadensis 30C, HPUSRelieves pain
Spigelia anthelmia 30C, HPUSRelieves pain

"HPUS" indicates that the ingredient is officially included in the Homeopathic Pharmacopeia of the United States and the manufacturer has followed all guidelines set forth.

Statement of Identity: Analgesic.

Uses

For the relief of painful headaches and to help shorten the duration of the headache.

Warnings

  • Do not use if outer package seal is broken.
  • If headache persists for more than 36 hours consult a doctor. New onset of headaches could be an indication of a serious underlying illness.
  • Do not give to children under 8 years of age.

Otc - Pregnancy Or Breast Feeding

  • If pregnant or breast-feeding, consult a health professional before use.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.

Directions

(adults and children 8 years of age and older)

Chew two tablets thoroughly, allowing each to dissolve in the mouth, then swallow. Repeat every 4 hours as needed.

Other Information

  • Safe to take with all other medications.
  • Store at 68-77°F (20-25°C) and keep out of direct sunlight.
  • Avoid humid or damp storage conditions. Close well when not in use.

Inactive Ingredients

Lactose, magnesium stearate (vegetable source), stevia leaf extract.

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