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 Ingredients | Purpose |
Belladonna 30C, HPUS | Relieves throbbing pains |
Bryonia 30C, HPUS | Relieves sharp pains |
Gelsemium sempervirens 30C, HPUS | Relieves heaviness in the head |
Sanguinaria canadensis 30C, HPUS | Relieves pain |
Spigelia anthelmia 30C, HPUS | Relieves 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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