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

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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Belladonna 30C HPUS (less than 0.000000000001% Alkaloids,calculated)

Calcarea Carbonica 30C HPUS

Chamomilla 30C HPUS

Lycopodium 30C HPUS

Pulsatilla 30C HPUS

Sulphur 30C HPUS

“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Purpose

Belladonna 30C HPUS..............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

Uses

Temporarily relieves the symptoms of:

• minor fever
• ear pain or throbbing
• irritability or occasional sleeplessness associated with earaches after diagnosis by a physician
• common pain or itching of “swimmer’s ear”

Warnings

Keep away from eyes. Do not take by mouth.

Earache drops are only to be used in ears. Tip of applicator should not enter ear canal.

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 101ºF).

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

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

Children ages 2 years and over:

Tilt head sideways and apply 3–4 drops into involved ear 4 times daily until relieved.

Tilt ear upward for at least 2 minutes after application or gently place cotton in ear to keep drops in.

Inactive ingredients

Citric Acid, Glycerine, Purified Water, Sodium Benzoate.

Questions or comments?

(800) 624-9659

SPL UNCLASSIFIED SECTION

*CLAIMS BASED ON TRADITIONAL

HOMEOPATHIC PRACTICE, NOT

ACCEPTED MEDICAL EVIDENCE.

NOT FDA EVALUATED.

Principal Display Panel - 10 mL Bottle Dropper Carton

New!

NDC: 54973-3392-1

HOMEOPATHIC

NATURAL

RELIEF

Ages

2-12

SINCE 1903

Hyland's

4 Kids

Earache Relief*

Swimmer's

Ear

Ear Pain

Fever

0.33 FL. OZ. (10 mL) Liquid Drops

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3392
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	30 [hp_C]  in 1 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	30 [hp_C]  in 1 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	30 [hp_C]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	30 [hp_C]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	30 [hp_C]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	30 [hp_C]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3392-1	1 in 1 CARTON	03/01/2019
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/01/2019

Labeler - Hyland’s (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-3392) , pack(54973-3392) , label(54973-3392)

Establishment
Name	Address	ID/FEI	Business Operations
Lifetech Resources		622559110	manufacture(54973-3392) , pack(54973-3392) , label(54973-3392)