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.
Earache Relief Tablet
FDA Label NDC 43689-0020
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Magni Company for the product Earache Relief (NDC 43689-0020). 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 active ingredients:, uses:, warnings:, keep out of reach of children:, other information:, directions:, indications:, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
