FDA Label for 4 Kids Earache Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- KEEP AWAY FROM EYES. DO NOT TAKE BY MOUTH.
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - DO NOT USE
- CONSULT A PHYSICIAN IF
- KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
- DIRECTIONS
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- OTHER
- PRINCIPAL DISPLAY PANEL - 10 ML BOTTLE DROPPER CARTON
4 Kids Earache Relief Product Label
The following document was submitted to the FDA by the labeler of this product Hyland�s. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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”
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.
Otc - Pregnancy Or Breast Feeding
As with any drug, ask a doctor before use if pregnant or breast-feeding.
Otc - Do Not Use
Do not use if you have ear tubes, damaged ear drums or after ear surgery.
Do not use if imprinted tamper-evident bottle cap band is broken or missing.
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).
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
Other
*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
* Please review the disclaimer below.