Your browser does not support JavaScript! COUNTERACT COUGH DROPS HONEY LEMON (MENTHOL) LOZENGE [MELALEUCA, INC.]
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COUNTERACT COUGH DROPS HONEY LEMON (menthol) lozenge
[Melaleuca, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

Active ingredient (in each drop)
Menthol 7 mg

Purpose
Cough suppressant, oral anesthetic

Uses temporarily relieves:

  • cough associated with a cold or inhaled irritants
  • occasional minor irritation, pain, sore mouth, and sore throat

Warnings
Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by physician.

Ask a doctor before use if you have

  • persistent of 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 a 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

If pregnant or breast-feeding, ask a health professional before use

Keep out of reach of children.

Directions

  • adults and children 5 years and over: dissolve 1 drop slowly in the mouth. May be repeated every hour as needed or as directed by a doctor.
  • children under 5 years: ask a doctor

Other information

  • store at room temperature
  • protect from moisture and heat

Inactive ingredients  ascorbic acid, beta-carotene, corn syrup, honey, lemon oil, sodium ascorbate, sucrose, T40-C3 brand Melaleuca Oil

image of bag
COUNTERACT  COUGH DROPS HONEY LEMON
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:54473-132
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL7 mg
Inactive Ingredients
Ingredient NameStrength
ASCORBIC ACID 
BETA CAROTENE 
CORN SYRUP 
HONEY 
LEMON OIL 
SODIUM ASCORBATE 
SUCROSE 
TEA TREE OIL 
Product Characteristics
Coloryellow (Bright Yellow) Scoreno score
ShapeOVAL (Drop) Size22mm
FlavorHONEY (Honey Lemon) Imprint Code P
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54473-132-3030 in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/20/2008
Labeler - Melaleuca, Inc. (139760102)

Revised: 6/2011
 
Melaleuca, Inc.

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