FDA Label for 4 Kids Oral Pain Relief
View Indications, Usage & Precautions
4 Kids Oral Pain 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.
Otc - Active Ingredient
Active ingredients | Purpose |
Arnica Montana 30X HPUS | tooth pain, sensitive or swelling gums |
Calcarea Carbonica 12X HPUS | tooth pain, sensitive gums or teeth |
Calcarea Phosphorica 12X HPUS | sensitive gums or teeth, oral pain |
Chamomilla 12X HPUS | tooth pain, sensitive gums or teeth |
Coffea Cruda 6X HPUS | tooth pain, irritability |
Ferrum Phosphoricum 12X HPUS | tooth pain, oral discomfort, swelling of gums |
“HPUS” indicates that the active ingredients are in the official Homeopathic
Pharmacopœia of the United States.
Uses
Temporarily relieves the symptoms of gum or tooth sensitivity, swelling of gums, tooth and oral pain and discomfort.
Warnings
As with any drug, ask doctor before use if pregnant or breast-feeding.
Do not use • more than directed • if your child has a known allergy to any ingredient in this product.
Consult a physician if: • symptoms persist for more than 72 hours or worsen • swelling increases, rash or fever develops
• irritation, pain or redness persists or worsens.
Otc - Keep Out Of Reach Of Children
Keep this and all medications out of the 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 band is broken or missing.
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 of age: dissolve 2 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved.
Children 6 years to under 12 years of age: dissolve 3 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved.
Adults and Children 12 years and over: dissolve 4 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved.
Hyland’s Oral Pain Relief Tablets are very soft and will dissolve instantly in the mouth.
Inactive Ingredient
Acacia Gum, Lactose.
Questions Or Comments?
(800) 624-9659
Otc - Purpose
Oral Pain Relief
Principal Display Panel - 125 Tablet Carton
New!
NDC 54973-3316-1
HOMEOPATHIC
Ages
2-12
Natural
Relief
SINCE 1903
Hyland's®
4 Kids
Oral Pain Relief
Toothache
Sensitive Teeth
Swelling Gums
Oral Disconfort
ACTUAL SIZE 65 MG
125 QUICK-DISSOLVING
TABLETS
SAFE &
EFFECTIVE
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