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  5. Label Information: Cold

FDA Label for Cold

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

Cold 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 - equal amounts of: Baptisia Tinctoria 4X, Echinacea Angustifolia 4X, Eupatorium Perfoliatum 4X, Lomatium Dissectum 4X, Pueraria Lobata 4X, Trifolium Pratense 4X, Phytolacca Decandra 6X, Allium Cepa 12X, Arsenicum Iodatum 12X, Baryta Carbonica 12X, Bromium 12X, Calcarea Carbonica 12X, Kali Muriaticum 12X, Lachesis Mutus 12X, Mercurius Solubilis 12X, Silicea 12X


Indications & Usage



USES: Temporarily relieves symptoms associated with the common cold.**


Otc - Purpose



USES: Temporarily relieves symptoms associated with the common cold.**


Dosage & Administration



DIRECTIONS: Adults & children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.


Otc - Keep Out Of Reach Of Children



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.


Warnings



WARNINGS:

  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health care 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.
  • 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 doctor.
  • Do not use if TAMPER EVIDENT seal is broken or missing.

Inactive Ingredient



INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water


Otc - Questions



QUESTIONS & COMMENTS?

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


References



**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Package Label.Principal Display Panel



NDC:43406-0688-1

Cold

HOMEOPATHIC

1 fl oz (30mL) / 20% Alcohol


* Please review the disclaimer below.