FDA Label for Headache Relief

View Indications, Usage & Precautions

Headache Relief Product Label

The following document was submitted to the FDA by the labeler of this product Homeostasis Laboratories, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.


Questions? Call Toll Free Or Email Us At:



1-888-60-B-WELL (1-888-602-9355)

[email protected]


* Please review the disclaimer below.