FDA Label for Baby Nighttime Oral Pain Relief
View Indications, Usage & Precautions
Baby Nighttime Oral Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product Hyland' 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 | sore, sensitive or swelling gums |
Calcarea Carbonica 12X HPUS | sore, sensitive or swelling gums |
Calcarea Phosphorica 12X HPUS | sensitive, swelling gums, oral pain |
Chamomilla 12X HPUS | sore, sensitive or swelling gums |
Coffea Cruda 6X HPUS | oral pain, irritability |
Ferrum Phosphoricum 12X HPUS | oral discomfort, swelling gums |
Magnesia Phosphorica 12X HPUS | oral pain, occasional sleeplessness |
Silicea 12X HPUS | oral pain at night, occasional sleeplessness |
“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
Uses
Temporarily relieves the symptoms of gum sensitivity, swelling or soreness of gums, and occasional sleeplessness due to oral discomfort.
Warnings
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
• if 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.
Tamper Evident
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 under 6 months of age: If child is restless or wakeful during the night, dissolve 1 tablet on tongue every 15 minutes for
4 doses, then hourly until relieved.
Children 6 months to 3 years of age: If child is restless or wakeful during the night,dissolve 2 tablets on tongue every 15 minutes for 4 doses, then hourly until relieved.
Hyland’s Baby Nighttime 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
NDC 54973-3324-1
HOMEOPATHIC
New!
SINCE 1903
Hyland's®
Baby
Natural
Relief
Nighttime
Oral Pain
Relief
RELIEF OF PAIN,
IRRITABILITY, SWELLING, AND
OCCASIONAL SLEEPLESSNESS
DUE TO ORAL DISCOMFORT*
► No Belladonna, Benzocaine, Artificial Flavors,
Dyes or Parabens
ACTUAL SIZE 65 MG
125 QUICK-DISSOLVING TABLETS
* Please review the disclaimer below.