Colds And Flu Response
FDA Label NDC 58066-7012

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Beaumont Bio Med for the product Colds And Flu Response (NDC 58066-7012). 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, warnings, otc - keep out of reach of children, other safety information, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

HPUS active ingredients:​ Anas barbariae, hepatis et cordis extractum (50C, 100C, 200C), Arsenicum album, Baptisia tinctoria, Bryonia, Dulcamara, Echinacea, Echinacea purpurea, Eupatorium perfoliatum, Ferrum phosphoricum, Gelsemium sempervirens, Kali muriaticum, Lac defloratum, Phosphorus, Pulsatilla, Sulphur, Zincum aceticum, Zincum carbonicum, Zincum metallicum, Zincum oxydatum, Zincum picricum, Zincum valerianicum. Equal volumes of each ingredient in 10X, 30X, 100X potencies, unless otherwise noted.

Inactive Ingredient

Inactive Ingredients: Alcohol 20%, (v/v) glycerin 8% (v/v), pure water base.

Indications & Usage

Indications: For temporary relief of: •body aches & pains •nasal congestion •headaches & fevers associated with the common cold and flu.

Use according to label indications under standard homeopathic indications.

Dosage & Administration

Directions: Hold close to mouth and spray 1 dose (3 complete pump sprays) directly in mouth 4-6 times daily until symptoms improve. Before initial dose, depress pump 4-5 times or until primed. Consult a physician for use in children under 12 years of age.

Warnings

Warnings: Stop use and ask a doctor if symptoms persist or worsen. If you are pregnant or breast feeding, consult a healthcare professional before use.

Otc - Keep Out Of Reach Of Children

  • Keep this and all medications out of reach of children.

Other Safety Information

Other Information: Tamper resistant for your protection. Use only if safety seal is intact. Contains 20% Ethyl Alcohol by Volume. In case of accidental overdose, contact a healthcare professional immediately.

Otc - Purpose

For temporary relief of:

  • body aches & pains
  • nasal congestion
  • headaches & fevers associated with the common cold and flu

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