Otc - Purpose
Relieves headache and nervous tension
Headache Soothe
FDA Label NDC 68703-085
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Native Remedies, Llc for the product Headache Soothe (NDC 68703-085). 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 - purpose, otc - active ingredient, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, overdosage, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredients: Each dose contains equal parts of: Chamomilla 12C HPUS, Cinchona 12C HPUS, Kali phos 6X HPUS, Mag phos 12X HPUS, Nux vom 12C HPUS
Indications & Usage
Uses: Homeopathic remedy for headache relief
Warnings
Warnings: If symptoms persist or worsen, consult a health care professional
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use it
Otc - Keep Out Of Reach Of Children
Keep this and all medication out of reach of children
Overdosage
In case of overdose, get medical help or contact Poison Control Center right away
Dosage & Administration
Directions: Adults and Children 13+: Mix 0.50 mL in 1/4 cup of water and sip slowly. Repeat every 20-30 minutes as needed until symptoms subside. If preferred, drops may betaken directly into the mouth. Children under 13: Reduce serving size to 0.25 mL
Inactive Ingredient
Inactive Ingredients: USP Purified water, grain alcohol (20% by volume), Lactose
Information For Patients
The letters HPUS indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States
All Native Remedies health products are especially formulated by expert in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.nativeremedies.com
Distributed by
Native Remedies, LLC
6531 Park of Commerce Blvd.
Suite 160
Boca Raton, FL 33487
Phone: +1.877.289.1235
International: +1.561.999.8857
Contains no animal products, glutenm artificial flavors, preservatives or colorants. Suitable for vegetarians and safe for all ages
Storage And Handling
Tamper resistant for your protection. Use only if seal is intact
Package Label.Principal Display Panel
Bottle Label (Hso001)
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