4 KIDS EARACHE RELIEF- atropa belladonna,oyster shell calcium carbonate, crude,lycopodium clavatum spore,anemone pulsatilla,sulfur and matricaria chamomilla liquid 
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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4 Kids Earache Relief

Purpose

Relieves earache due to swimmer’s ear, cold, flu & allergy

Drug Facts

Active ingredients

Purpose

Belladonna 30C HPUS

(less than 0.000000000001% Alkaloids, calculated)

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

Sulphur 30C HPUS

ear pain with burning

"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Uses

Temporarily relieves symptoms of earache in children, including: ■ minor fever ■ ear pain or throbbing ■ common pain or

itching of "swimmer’s ear" ■ irritability or occasional sleeplessness associated with earaches after diagnosis by a physician

Warnings

Keep away from eyes. Do not take by mouth.

Earache drops are only to be used in ears.

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

Do not use if you have ear tubes, damaged ear drums or after ear surgery.

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).

Drug Facts (continued)

Keep this and all medications out of the reach of children. If swallowed, 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

■ Shake well before using.

Children ages 2 years and over: Tilt head sideways and apply 3-4 drops into involved ear (Tip of applicator should not enter ear canal). Keep head tilted for at least 2 minutes to keep drops in ear. Repeat until relieved, up to 4 times daily.

Other information

■ Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.

■ Store at room temperature.

■ Do not refrigerate.

Inactive ingredients

Citric Acid, Glycerine, Purified Water, Sodium Benzoate.

Questions or comments?

(800) 624-9659

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

Principal Display Panel

HOMEOPATHIC

NDC 54973-3392-1

2-12

YEARS

NEW

LOOK

4 KIDS

SINCE 1903

Hyland's

Earache

Relief*

Relieves earache

due to swimmer’s ear,

cold, flu & allergy

NO DYES or PARABENS

NO NUMBING EFFECT

NATURAL

RELIEF*

0.33 FL. OZ. (10 mL)

*SEE NOTE ON SIDE

PANEL BELOW DRUG FACTS

Carton

4 KIDS EARACHE RELIEF 
atropa belladonna,oyster shell calcium carbonate, crude,lycopodium clavatum spore,anemone pulsatilla,sulfur and matricaria chamomilla liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3392
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA30 [hp_C]  in 1 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE30 [hp_C]  in 1 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA30 [hp_C]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA30 [hp_C]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR30 [hp_C]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE30 [hp_C]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-3392-11 in 1 CARTON03/01/2019
110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/01/2019
Labeler - Hyland’s (008316655)

Revised: 11/2022
Document Id: ee179f50-a7e0-8a0f-e053-2a95a90a876e
Set id: 7ee2a9f8-4a16-4a9d-e053-2a91aa0a1be7
Version: 5
Effective Time: 20221122
 
Hyland’s