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

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 4 Kids Earache Relief

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

carton

4 KIDS EARACHE RELIEF 
matricaria chamomilla,ferric phosphate,sulfur,oyster shell calcium carbonate, crude,lycopodium clavatum spore and anemone pulsatilla tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3393
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA30 [hp_C]
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE30 [hp_C]
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE30 [hp_C]
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA30 [hp_C]
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE30 [hp_C]
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR30 [hp_C]
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
Product Characteristics
Colorwhite (to Off-White) Scoreno score
ShapeROUNDSize9mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-3393-11 in 1 CARTON12/01/2018
140 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/01/2018
Labeler - Hyland's Inc. (008316655)
Establishment
NameAddressID/FEIBusiness Operations
Hyland's Inc.008316655manufacture(54973-3393) , pack(54973-3393) , label(54973-3393)

Revised: 11/2022
Document Id: ee178924-32b4-b5f4-e053-2995a90a6a07
Set id: 7a7facbe-f245-d991-e053-2a91aa0aa26f
Version: 2
Effective Time: 20221122
 
Hyland's Inc.