FDA Label for 4 Kids Sore Throat Grape
View Indications, Usage & Precautions
4 Kids Sore Throat 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 15X HPUS
Ferrum Phosphoricum 12X HPUS
Hepar Sulphuris Calcareum 12X HPUS
Phosphorus 9X HPUS
Spongia Tosta 12X HPUS
HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
Purpose
sore throat
sore throat
sore throat
pain in throat
sore throat
Uses
- Temporarily relieves sore throat symptoms in children, including:
- occasional minor irritation
- pain
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 7 days or worsen.
- inflammation, fever or infection develops.
- symptoms are accompanied by a high fever (over 101°F).
Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly.
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 up to 6 times per day (every 4 hours). |
Children 6 years to under 12 years | 10 mL up to 6 times per day (every 4 hours). |
Adults and children 12 years and over | 15 mL up to 6 times per day (every 4 hours). |
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 54973-4020-1
2-12
YEARS
NEW
4 KIDS
SINCE 1903
Hyland's
Sore
Throat*
Relieves minor
sore throat pain
and irritation
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.