FDA Label for Hallsmelon Splash Melon Splash

View Indications, Usage & Precautions

Hallsmelon Splash Melon Splash Product Label

The following document was submitted to the FDA by the labeler of this product Mondelez Global Llc. 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 Ingredient



<(in each drop) Menthol 3.1 mg>


Purposes



<Cough Suppressant, Oral Anesthetic>


Uses



<temporarily relieves:>

  • cough due to a cold
  • occasional minor irritation or sore throat

Warnings



<Sore throat warning:  if sore throat is severe, persist for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.  These may be serious.>


Ask A Doctor Before Use If You Have



  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanied by excessive phlegm (mucus)

Stop Use And Ask A Doctor If



  • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache.  these could be signs of a serious condition.
  • sore mouth does not improve in 7 days
  • irritation, pain, or redness persists or worsens

Keep Out Of Reach Of Children



Enter section text here


Directions



  • adults and children 5 years and over:  dissolve 2 drops (one at a time) slowly in the mouth.  Repeat every 2 hours as needed.
  • children under 5 years:  ask a doctor

Other Information



  • 15 calories per drop
  • contains: soy

Inactive Ingredients



<citric acid, eucalyptus oil, FDC blue 1, FDC yellow 5 (tartrazine), flavors, glucose syrup, potassium citrate, soy lecithin, sucrose, water>


Questions



<Call 1-800-524-2854, Monday to Friday, 9AM-6PM Eastern Time or visit our website at www.gethalls.com>


Principal Display Panel



<Halls Melon Splash US NDC 12546-315-09 and CA NDC 67238-315-09>


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