FDA Label for 4 Kids Earache Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- OTC - PREGNANCY OR BREAST FEEDING
- CONSULT A PHYSICIAN IF
- OTC - KEEP OUT OF REACH OF CHILDREN
- OTC - DO NOT USE
- THE INNER PACKAGED BOTTLE IS CHILD RESISTANT.
- IN CASE OF EMERGENCY
- DIRECTIONS
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - 40 TABLETS BOTTLE CARTON
4 Kids Earache Relief Product Label
The following document was submitted to the FDA by the labeler of this product Hyland's Inc.. 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
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
Otc - Pregnancy Or Breast Feeding
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 101°F).
Otc - Keep Out Of Reach Of Children
Keep this and all medications out of reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately.
Otc - Do Not Use
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
* Please review the disclaimer below.