EARACHE- matricaria chamomilla, atropa belladonna, oyster shell calcium carbonate, crude, sulfur, pulsatilla vulgaris and lycopodium clavatum spore tablet

Earache by

Drug Labeling and Warnings

Earache by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's, Standard Homeopathic Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

• Active ingredients:

  Purpose

• Belladonna 30C HPUS:

  minor fever

• Calcarea Carbonica 30C HPUS:

  throbbing ear pain

• Chamomilla 30C HPUS:

  occasional sleeplessness and irritability

• Lycopodium 30C HPUS:

  ear pain

• Pulsatilla 30C HPUS:

  ear itching, pain worse at night,minor fever

• Sulphur 30C HPUS:

  ear pain with burning,minor fever

“HPUS” indicates that the active ingredients are in the official

Homeopathic Pharmacopoeia of the United States.

minor fever

throbbing ear pain

occasional sleeplessness and irritability

ear pain

ear itching, pain worse at night, minor fever

ear pain with burning, minor fever

Uses

• Temporarily relieves the symptoms of:
• minor fever 
• ear pain or throbbing
• occasional sleeplessness or irritability associated with earaches after diagnosis by a physician

Warnings

As with any drug, ask a doctor before use if pregnant or breast-feeding.

Do not use more than directed.

Consult a physician if: 

• symptoms persist for more than 48 hours or worsen.
• discharge from ear is present. 
• symptoms are accompanied by a high fever (over 101°F).

Keep this and all medications out of the reach of children.

In case of emergency or accidental overdose, contact a medical professional or Poison

Control Center immediately. Hyland’s may also be contacted for emergency information

about our products 24 hours a day, 7 days per week at (800) 624-9659.

Directions

• Adults and children 12 years and over:

  Dissolve 2-3 tablets under tongue every 8 hours

  until relieved for up to 48 hours.

Other information

• Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident

bottle cap band is broken or missing.

• The inner packaged bottle is child-resistant.

INACTIVE INGREDIENT

Acacia Gum, Lactose.

Questions or comments?

(800) 624-9659

SPL UNCLASSIFIED SECTION

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE,

NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

Principal Display Panel - 40 Tablet Carton

NDC: 54973-3169-1

HOMEOPATHIC

Natural

Relief

SINCE 1903

Hyland's®

EARACHE

TABLETS

RELIEVES EAR PAIN FAST*

CALMS & SOOTHES

EARACHES DUE TO:

• COLD & FLU
• ALLERGY
• MINOR FEVER

40 QUICK-DISSOLVING TABLETS

ACTUAL SIZE 194 MG

*SEE NOTE ON BACK PANEL

BELOW DRUG FACTS

INGREDIENTS AND APPEARANCE

EARACHE 
matricaria chamomilla, atropa belladonna, oyster shell calcium carbonate, crude, sulfur, pulsatilla vulgaris and lycopodium clavatum spore tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3169
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	30 [hp_C]  in 1 g
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	30 [hp_C]  in 1 g
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	30 [hp_C]  in 1 g
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	30 [hp_C]  in 1 g
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	30 [hp_C]  in 1 g
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	30 [hp_C]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ACACIA (UNII: 5C5403N26O)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)

Product Characteristics
Color	white (Off-White)	Score	no score
Shape	ROUND	Size	3mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3169-1	1 in 1 CARTON	04/15/2013
1		40 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/15/2013

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-3169) , pack(54973-3169) , label(54973-3169)