Otc - Active Ingredient
Active ingredients (Ref. stand.) Cherry plum 5X (HPUS) Clematis erecta 5X (HPUS) Impatiens gland 5X (HPUS) Rock rose 5X (HPUS) Star of bethlehem 5X (HPUS)
Bm Rescue Remedy (instant Calm) Spray
FDA Label NDC 85816-6025
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bm Private Limited for the product Bm Rescue Remedy (instant Calm) (NDC 85816-6025). 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, otc - purpose, indications & usage, dosage & administration, contraindications, warnings, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Ethanol 30%, Glycerin
Otc - Purpose
Indications: As advised by a homoeopathic physician.
Indications & Usage
Indications: As advised by a homoeopathic physician.
Dosage & Administration
How to use: 2 puff 3 times a day, spray under the tongue. Hold for 30 seconds, and then swallow.
Contraindications
Care & contra-indications: This is a homoeopathic remedy, no contra-indications are established.
Warnings
Precautions/storage: Keep away from children and store at cool and dry place.
Otc - Keep Out Of Reach Of Children
Precautions/storage: Keep away from children and store at cool and dry place.
Storage And Handling
Precautions/storage: Keep away from children and store at cool and dry place.
Package Label.Principal Display Panel
Entire package label
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