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

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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Hyland's Earache Tablets

Drug Facts

Active ingredients	Purpose
Belladonna 30C HPUS	minor fever
(less than 0.000000000001% Alkaloids, calculated)
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.

Acacia Gum, Lactose.

Questions or comments?

(800) 624-9659

*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

CARTON

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		04/15/2013	12/28/2021

Labeler - Hyland's (028570695)

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

Revised: 12/2021

Document Id: d43d4484-9f50-0998-e053-2995a90a0533

Set id: 56bdf20b-0a8a-4532-e054-00144ff8d46c

Version: 3

Effective Time: 20211228

Hyland's