Cold And Flu Relief
FDA Label NDC 50441-0005

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharmwest Inc. for the product Cold And Flu Relief (NDC 50441-0005). 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 indications & usage, otc - active ingredient, inactive ingredient, 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

Indications & Usage

Uses: Temporarily relieves symptoms of: chills, fever, body aches, headaches, nasal congestion, fatigue, sneezing, sore throat, cough, diarrhea, nausea, and vomiting.

Otc - Active Ingredient

Ingredients: (Official HPUS): ​Aconitum napellus, Arsenicum album, Baptisia tinctoria, Bryonia, Causticum, Cinchona officinalis, Echinacea purpurea, Eucalyptus globulus, Eupatorium perfoliatum, Gelsemium sempervirens, Influenzinum, Phytolacca decandra, Rhus toxicodendron, Sarcolacticum acidum, Sulphur, Wyethia helenioides, Zincum aceticum, Zincum muriaticum, Zincum oxydatum. Equal volumes of each ingredient: 10X, 30X, LM1 potencies.

Inactive Ingredient

Inactive ingredients: Citric acid, potassium sorbate, pure water base.

Dosage & Administration

Directions: Spray directly into mouth.

Adult Dose: 3 pump sprays 3 times daily.

Children's Dose (ages 2-12): 2 pump sprays, 3 times daily.

Use additionally as needed.

Warnings

Warnings: If symptoms persist or worsen, stop usage and consult a physician. If pregnant or breast-feeding, take only upon advice of a healthcare professional.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.

Other Safety Information

Tamper resistant for your protection. Use only if safety seal is intact.

Otc - Purpose

Uses: Temporarily relieves symptoms of:

  • Sore Throat & Cough
  • Fever & Chills
  • Body Aches
  • Stuffy Nose
  • Sneezing
  • Fatigue
  • Headaches

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