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  5. Label Information: Earache Relief

FDA Label for Earache Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS:
    2. USES:
    3. WARNINGS:
    4. KEEP OUT OF REACH OF CHILDREN:
    5. OTHER INFORMATION:
    6. DIRECTIONS:
    7. INDICATIONS:
    8. INACTIVE INGREDIENTS:
    9. QUESTIONS:
    10. PACKAGE LABEL DISPLAY:

Earache Relief Product Label

The following document was submitted to the FDA by the labeler of this product The Magni Company. 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.

Active Ingredients:



Belladonna 12X, Calcarea Carbonica 12X, Chamomilla 12X, Hepar Sulphuris Calcareum 12X, Kali Bichromicum 12X, Lycopodium Clavatum 12X, Plantago Major 12X, Pulsatilla (Vulgaris) 12X.


Uses:



For temporary relief of earache symptoms, such as pain, pressure, congestion, itching, sleeplessness, and headaches, after diagnosis by a physician.


Warnings:



• If pregnant or breastfeeding, ask a health professional before use.

• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

• Stop use and ask a doctor if you experience worsening symptoms or if symptoms last longer than 7 days.


Keep Out Of Reach Of Children:



Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


Other Information:



• Store tightly closed in a cool, dry place (59° - 86°F)

• Tamper sealed: Sealed for your protection. Do not use if seal is broken or missing

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

• These statements are supported by the traditional homeopathic principles


Directions:



Adults and children 12 years and above:  dissolve 1-2 tablets under tongue, 2 to 3 times daily or as directed by a physician.

Children under 12 years, consult a physician.


Indications:



For temporary relief of earache symptoms, such as pain, pressure, congestion, itching, sleeplessness, and headaches, after diagnosis by a physician.


Inactive Ingredients:



Lactose, Magnesium Stearate, Microcrystalline Cellulose


Questions:



Dist. by: The Magni Group, Inc. McKinney, TX 75071 USA

www.magnilife.com                               1-800-645-9199


Package Label Display:



MAGNILIFE Homeopathic

NDC 43689-0020-1

EARACHE RELIEF

Targets ear pain
for fast relief

Soothes ear pain and
discomfort due to:
√ Allergy
√ Cold & Flu
√ Congestion
√Swimmer's Ear

90 Dissolving Tablets


* Please review the disclaimer below.