Halls Tropical Fruit

Dosage form: lozenge
Ingredients: MENTHOL 2.7mg
Labeler: Kraft Foods Global, Inc.
NDC Code: 12546-115

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active Ingredient(in each drop) Menthol 2.7 mg

PurposesCough Suppressant, Oral Anesthetic

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

WarningsSore 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
  • 12 calories per drop
  • Contains:  SOY

Inactive ingredientsbeta carotene, eucalyptus oil, FDC red 40, flavors, glucose syrup, potassium citrate, soy lecithin, sucrose, water

QuestionsCall 1-800-524-2854, Monday to Friday, 9AM-6PM Eastern Time or visit our website atwww.gethalls.com

OTC Principal Display Panel

Enter section text hereNDC  12546-115-30 Halls Tropical Fruit 30 drops bag

HALLS  TROPICAL FRUIT
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12546-115
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL2.7 mg
Inactive Ingredients
Ingredient NameStrength
BETA CAROTENE 
EUCALYPTUS OIL 
FD&C RED NO. 40 
POTASSIUM CITRATE 
LECITHIN, SOYBEAN 
SUCROSE 
WATER 
Product Characteristics
Colororange (light orange) Scoreno score
ShapeOVALSize21mm
FlavorFRUIT (Tropical Fruit) Imprint Code H
Contains    
Packaging
#Item CodePackage Description
1NDC:12546-115-3030 LOZENGE (LOZENGE) in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/01/2012
Labeler - Kraft Foods Global, Inc. (039010590)

Revised: 03/2012
 
Kraft Foods Global, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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