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  5. Label Information: Cough Syrup

FDA Label for Cough Syrup

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. INDICATIONS & USAGE
    3. OTC - PURPOSE
    4. DOSAGE & ADMINISTRATION
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. WARNINGS
    7. INACTIVE INGREDIENT
    8. OTC - QUESTIONS
    9. REFERENCES
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cough Syrup Product Label

The following document was submitted to the FDA by the labeler of this product Natural Creations, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



ACTIVE INGREDIENTS (HPUS*): Camphora 3X, 30C, Arsenicum Album 30C, Bryonia Alba 30C, Drosera Rotundifolia 30C, Ipecacuanha 30C, Kali Carbonicum 30C, Phosphorus 30C, Pulsatilla 30C, Spongia Tosta 30C, Squilla Maritima 30C.


Indications & Usage



USES: Temporarily relieves dry cough, dry barking cough, dry, hacking, painful cough, incessant coughing, dry rattling cough, congestion and tightness of chest, shortness of breath, and/or other symptoms related to coughing.**


Otc - Purpose



USES: Temporarily relieves dry cough, dry barking cough, dry, hacking, painful cough, incessant coughing, dry rattling cough, congestion and tightness of chest, shortness of breath, and/or other symptoms related to coughing.**


Dosage & Administration



DIRECTIONS: Adults & children above 4 years: 1 teaspoon (5mL) every 2-3 hours, or as directed by a health care professional. Shake well before use.


Otc - Keep Out Of Reach Of Children



KEEP OUT OF THE REACH OF CHILDREN. In case ov overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.


Warnings



WARNINGS:

  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
  • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
  • Do not use if TAMPER EVIDENT seal is broken or missing.

Inactive Ingredient



INACTIVE INGREDIENTS: Acacia Gum, Anise Oil, Citric Acid, Eucalyptus Oil, Glycerin, Herbal Base [Chamomile (flower), Echinacea Angustifolia (Flower), Iceland Moss (Herb), Marshmallow (Root), Mullein (Leaf), Plantain (Leaf), Red Clover (Flower), Stinging Nettle (Leaf), Thyme (Herb)], Honey, Natural Cherry Flavor, Natural Mixed Berry Flavor, Potassium Sorbate, Purified Water.


Otc - Questions



QUESTIONS & COMMENTS?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600


References



*The letters "HPUS" indicate the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.

**These statements have not been reviewed by the FDA. They are based on traditional homeopathic practice.


Package Label.Principal Display Panel



NDC: 43406-0664-4

COUGH SYRUP

HOMEOPATHIC

Natural Cherry / Mixed Berry Flavor

4 fl oz (120 mL)


* Please review the disclaimer below.