Wellness4cough Syrup
FDA Label NDC 64471-330

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Source Naturals for the product Wellness4cough Syrup (NDC 64471-330). 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, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, 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:

  • Althaea officinalis 1x
  • Prunus virginiana 1x
  • Inula helenium 3x
  • Marrubium vulgare 3x
  • Eucalyptus globulus 6x
  • Rumex crispus 6x
  • Sanguinaria canadensis 6x
  • Bryonia alba 12x
  • Causticum 12x
  • Nux vomica 12x
  • Phosphorus 12x
  • Pulsatilla nigricans 12x

Otc - Purpose

  • Homeopathic cough syrup for kids and teens

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children

Indications & Usage

  • For the temporary relief of coughs and congestion due to cold and flu.
  • Helps loosen mucus (expectorant) and clear bronchial congestion.
  • Soothes sore throat.
    •         For best Results:
        • Keep mouth free of food and strong tastes for 15 minutes before and after taking.
          • Hold liquid in mouth for 10-15 seconds before swallowing.

Warnings

  • In case of overdose get medical help or contact poison control center right away
  • A persistent cough may be a sign of a serious condition
  • If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a physician
  • Do not give this product for persistent or chronic cough associate with smoking, asthma, emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a physician
  • As with any medicine, if you are pregnant, may become pregnant, or breasfeeding, seek the advice of a health care professional before using this product

Dosage & Administration

  • Adults and children 12 years of age and older:   
    • Take 2 teaspoons every 4 hours
    • Or as needed
      • Children 2 - 12 years of age:
        • Take 1 teaspoon every 4 hours  
        • Or as needed
          • Children under 2: Consult a physician for use

Inactive Ingredient

Inactive Ingredients:

  • Deionized water
  • Fructose
  • Natural Cherry flavor
  • Vanilla flavor
  • Natural color
  • Citric acid
  • Potassium Benzoate
  • Xanthan gum


Package Label.Principal Display Panel

Image Of Label (Bottlelabel)

Image Of Label (Bottlelabel)

Wellness4

bottle label image

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