EARACHE- belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, pulsatilla patens, and sulfur 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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EARACHE TABLETS

Drug Facts

Active Ingredient	Purposes
"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Belladonna 30C HPUS	Fever
Calcarea Carbonica 30C HPUS	Throbbing ear pain
Chamomilla 30C HPUS	Sleeplessness and irritability
Lycopodium 30C HPUS	Ear pain
Pulsatilla 30C HPUS	Ear itching, pain worse at night
Sulphur 30C HPUS	Ear pain with burning

Uses

Temporarily relieves the symptoms of fever, pain, throbbing, irritability and sleeplessness associated with earaches after diagnosis by a physician. Relieves common pain and itching of "swimmer's ear."

Warnings

As with any drug, ask a doctor before use if pregnant or nursing. Consult a physician if:

Symptoms persist for more than 48 hours
Discharge from the ear is present

Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or poison control center immediately.

In case of emergency, 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 2 years and up

Dissolve 4 tablets under the tongue 3 times per day for 48 hours or until symptoms subside. If you prefer, tablets may be dissolved in a teaspoon of water. Earache Tablets are very soft and dissolve almost instantly under the tongue.

Inactive Ingredients

Acacia Gum, Lactose N.F.

Questions or comments?

(800) 624-9659

PRINCIPAL DISPLAY PANEL - 4 x 10 Tablet Blister Pack Carton

NDC 54973-7507-1
HOMEOPATHIC • MADE IN USA

SINCE 1903
Hyland's®

EARACHE
TABLETS

RELIEVES EAR PAIN FAST

CALMS & SOOTHES EARACHES DUE TO

COLD & FLU
SWIMMER'S EAR
ALLERGY

40 TABLETS

Principal Display Panel - 4 x 10 Tablet Blister Pack Carton

EARACHE
belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, pulsatilla patens, and sulfur tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54973-7507
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BELLADONNA LEAF (UNII: 6GZW20TIOI) (BELLADONNA LEAF - UNII:6GZW20TIOI)	BELLADONNA LEAF	30 [hp_C]
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	30 [hp_C]
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	30 [hp_C]
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	30 [hp_C]
PULSATILLA PATENS (UNII: 4M1169RWJD) (PULSATILLA PATENS - UNII:4M1169RWJD)	PULSATILLA PATENS	30 [hp_C]
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	30 [hp_C]

Ingredient Name	Strength
Inactive Ingredients
ACACIA (UNII: 5C5403N26O)
LACTOSE (UNII: J2B2A4N98G)

Product Characteristics
Color	white (OFF-WHITE)	Score	no score
Shape	ROUND	Size	5mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54973-7507-1	4 in 1 CARTON	01/01/1999	12/21/2017
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/01/1999	12/21/2017

Labeler - Hyland's (028570695)

Name	Address	ID/FEI	Business Operations
Establishment
Standard Homeopathic Company		008316655	manufacture(54973-7507)

Revised: 12/2017

Document Id: 60dd9e54-f121-f7fe-e053-2a91aa0aeeeb

Set id: 3f785805-639d-4d62-af67-f7bb981eced2

Version: 2

Effective Time: 20171221

Hyland's