EARACHE RELIEF (belladonna, calcarea carbonica, chamomilla, hepar sulphuris calcareum, kali bichromicum, lycopodium clavatum, plantago major, pulsatilla- vulgaris tablet

Earache Relief by

Drug Labeling and Warnings

Earache Relief by is a Homeopathic medication manufactured, distributed, or labeled by The Magni Company, Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

EARACHE RELIEF 
belladonna, calcarea carbonica, chamomilla, hepar sulphuris calcareum, kali bichromicum, lycopodium clavatum, plantago major, pulsatilla (vulgaris) tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43689-0020
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	12 [hp_X]
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	12 [hp_X]
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	12 [hp_X]
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	12 [hp_X]
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V)	POTASSIUM DICHROMATE	12 [hp_X]
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	12 [hp_X]
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U)	PLANTAGO MAJOR	12 [hp_X]
PULSATILLA VULGARIS (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	PULSATILLA VULGARIS	12 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	white	Score	no score
Shape	ROUND (Convex)	Size	6mm
Flavor		Imprint Code	ML
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43689-0020-2	1 in 1 PACKAGE	08/24/2016
1	NDC: 43689-0020-1	90 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/09/2016

Labeler - The Magni Company (113501902)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43689-0020) , api manufacture(43689-0020) , label(43689-0020) , pack(43689-0020)