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  5. Label Information: Throat

FDA Label for Throat

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

Throat 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*) - equal amounts of: Baptisia 6X, Phytolacca 6X, Hydrastis 6X, Apis mel 12X, Arg Nit 12X, Belladonna 12X, Hepar Sulph Calc 12X, Kali Bic 12X, Lac Can 12X, Lachesis 12X, Merc Solub 12X


Indications & Usage



USES: Temporarily relieves sore, raw, rough-feeling, tickling cough, hoarseness, &/or other symptoms due to a sore throat.**


Otc - Purpose



USES: Temporarily relieves sore, raw, rough-feeling, tickling cough, hoarseness, &/or other symptoms due to a sore throat.**


Dosage & Administration



DIRECTIONS: Spray 3 to 5 times towards back of the throat as needed 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: Clove Bud, Ethyl Alcohol USP, Glycerin USP, Marshmallow Root, Menthol Crystals, Myrrh Gum, Purified Water, Sage leaves, Thyme Leaves, Yellow Dock Root


Otc - Questions



QUESTIONS & COMMENTS?

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


References



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

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


Package Label.Principal Display Panel



NDC:43406-0718-2

Throat Spray

HOMEOPATHIC

2 fl oz (60mL) / 20% Alcohol


* Please review the disclaimer below.