The following Structured Product Label (SPL) was submitted to the FDA by Speer Laboratories, Llc for the product Soothe Remedy No. 20 (NDC 55926-0020). 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, inactive ingredient, indications & usage, dosage & administration, otc - keep out of reach of children, warnings, other safety information, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredients 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.
Equal volumes of each ingredient in: 10X, 30X, LM1 potencies
HPUS indicates that this ingredient is officially part of the Homeopathic Pharmacopeia of the United States.
Inactive Ingredients: Citric acid, Potassium sorbate, Purified water.
Uses: Temporarily relieves symptoms of:
Directions:
Hold close to mouth and spray directly into mouth. Use 3 times daily. Use additionally as needed. For adults only. Adult dose 3 pump sprays.
Keep out of reach of children.
Warnings: Stop use and ask a doctor if symptoms persist, worsen or if new symptoms occur. If pregnant or breastfeeding, consult a doctor before use.
Tamper resistant for your protection. Use only if safety seal is still intact.
Uses: Temporarily relieves symptoms of: headache pain (throbbing, splitting, tight, dull, sick, bursting, sinus, congestive, migraine, occipital, etc), band feeling around the head, morning headache, sun headache.
Image Description (Soothe)
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