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

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Drug Facts:

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

Earache Relief   lbl

Earache Relief    ctn

EARACHE RELIEF 
belladonna, calcarea carbonica, chamomilla, hepar sulphuris calcareum, kali bichromicum, lycopodium clavatum, plantago major, pulsatilla (vulgaris) tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43689-0020
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA12 [hp_X]
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]
MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA WHOLE12 [hp_X]
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE12 [hp_X]
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE12 [hp_X]
PLANTAGO MAJOR WHOLE (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR WHOLE12 [hp_X]
PULSATILLA VULGARIS WHOLE (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) PULSATILLA VULGARIS WHOLE12 [hp_X]
Inactive Ingredients
Ingredient NameStrength
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUND (Convex) Size6mm
FlavorImprint Code ML
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43689-0020-21 in 1 PACKAGE08/24/2016
1NDC:43689-0020-190 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic05/09/2016
Labeler - The Magni Company (113501902)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43689-0020) , api manufacture(43689-0020) , label(43689-0020) , pack(43689-0020)

Revised: 1/2022
Document Id: 6aacf650-2a06-4382-8756-b28ddec2644d
Set id: 3f62001a-27b5-43cb-8006-110943facf87
Version: 3
Effective Time: 20220110
 
The Magni Company