4 KIDS EARACHE RELIEF- matricaria chamomilla,ferric phosphate,sulfur,oyster shell calcium carbonate, crude,lycopodium clavatum spore and anemone pulsatilla tablet

4 Kids Earache Relief by

Drug Labeling and Warnings

4 Kids Earache Relief by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Calcarea Carbonica 30C HPUS

Chamomilla 30C HPUS

Ferrum Phosphoricum 30C HPUS

Lycopodium 30C HPUS

Pulsatilla 30C HPUS

Sulphur 30C HPUS

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

Pharmacopœia of the United States.

Purpose

Calcarea Carbonica 30C HPUS.....................................................throbbing ear pain

Chamomilla 30C HPUS ...............................occasional sleeplessness and irritability

Ferrum Phosphoricum 30C HPUS...........................................................minor fever

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

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.

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 101ºF).

Keep this and all medications out of reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

Do not use if imprinted tamper-evident bottle cap band is broken or missing.

The inner packaged bottle is child resistant.

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

• Children 2 years to under 6 years:

  Dissolve 2 tablets under tongue every 8 hours

  until relieved for up to 48 hours.

• Children 6 years to under 12 years:

  Dissolve 3 tablets under tongue every 8 hours

  until relieved for up to 48 hours.

• Adults and children 12 years and over:

  Dissolve 4 tablets under tongue every 8 hours

  until relieved for up to 48 hours.

Inactive ingredients

Acacia Gum, Lactose.

Questions or comments?

(800) 624-9659

Principal Display Panel - 40 Tablets Bottle Carton

New!

NDC: 54973-3393-1

HOMEOPATHIC

Ages

2-12

NATURAL

RELIEF

SINCE 1903

Hyland's

4 Kids

Earache Relief*

Ear Pain

Fever

Irritability

40 QUICK-DISSOLVING TABLETS

ACTUAL SIZE 194 MG

INGREDIENTS AND APPEARANCE

4 KIDS EARACHE RELIEF 
matricaria chamomilla,ferric phosphate,sulfur,oyster shell calcium carbonate, crude,lycopodium clavatum spore and anemone pulsatilla tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3393
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]
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7)	FERROSOFERRIC PHOSPHATE	30 [hp_C]
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	30 [hp_C]
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	30 [hp_C]
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	30 [hp_C]
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	30 [hp_C]

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

Product Characteristics
Color	white (to Off-White)	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3393-1	1 in 1 CARTON	12/01/2018
1		40 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		12/01/2018

Labeler - Hyland's Inc. (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-3393) , pack(54973-3393) , label(54973-3393)