FDA Label for 4 Kids Pain Relief Grape
View Indications, Usage & Precautions
4 Kids Pain Relief Grape 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
Aconitum Napellus 30X HPUS
Arnica Montana 30X HPUS
Bryonia Alba 30X HPUS
Eupatorium Perfoliatum 30X HPUS
Gelsemium Sempervirens 12X HPUS
Phosphorus 12X HPUS
Pulsatilla 9X HPUS
Rhus Toxicodendron 12X HPUS
"HPUS" indicates that the active ingredients are in the
official Homeopathic Pharmacopoeia of the United States.
Purpose
headache, back pain,minor pain in joints
muscle aches, pain
back pain, minor pain in joints
pain in back and limbs
muscle aches/pain, headache
minor pain in joints, headache
toothache, minor pain in joints
stiffness, minor pain in joints, cramps
Uses
- Temporarily relieves minor pain symptoms in children, including:
- muscle aches
- toothache
- headache
- cramps
- stiffness
- back pain
- pain in joints or limbs
Warnings
As with any drug, ask a doctor before use if pregnant or breast-feeding.
Other
Do not use more than directed.
Consult a physician if:
- symptoms persist for more than 48 hours or worsen.
- inflammation, fever or infection develops.
- symptoms are accompanied by a high fever (over 101°F).
In case of emergency or accidental overdose, 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.
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
Otc - Keep Out Of Reach Of Children
Keep this and all medications out of the reach of children.
Directions
- Shake well before using.
- Measure only with the dosing cup provided.
- Do not use dosing cup with other products.
- On dosing cup, mL = milliliter.
Children 2 years to under 6 years | 5 mL every 15 minutes for 4 doses, then every 4 hours until relieved. |
Children 6 years to under 12 years | 10 mL every 15 minutes for 4 doses, then every 4 hours until relieved. |
Adults and children 12 years and over | 15 mL every 15 minutes for 4 doses, then every 4 hours until relieved. |
Other Information
- Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.
- The inner packaged bottle is child-resistant.
- Store at room temperature.
- Do not refrigerate.
Inactive Ingredients
Citric Acid, Glycerine, Glycyrrhiza Extract, Natural Grape Flavor, Purified Water, Sodium Benzoate.
Questions Or Comments?
(800) 624-9659
Principal Display Panel - 118 Ml Bottle Carton
HOMEOPATHIC
NDC 54973-4018-1
2-12
YEARS
NEW
4 KIDS
SINCE 1903
Hyland's
Pain
Relief*
Relieves muscle aches,
headache, minor joint
pain and toothache
NO ACETAMINOPHEN
NO ALCOHOL or PARABENS
NO SUGAR or DYES
NATURAL
RELIEF
NATURAL
GRAPE
FLAVOR
4 FL. OZ. (118 mL)
*SEE NOTE
ON SIDE PANEL
BELOW DRUG FACTS
* Please review the disclaimer below.