CounterAct Cough Drops Orchard Cherry

Dosage form: lozenge
Ingredients: MENTHOL 7mg
Labeler: Melaleuca, Inc.
NDC Code: 54473-131

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.

CounterAct Cough Drops Orchard Cherry Content of Label

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 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 a fever, rash, or persistent headache. These can 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, cherry flavor (artificial), corn syrup, fruit and vegetable extracts, sodium ascorbate, sucrose, T40-C3 brand Melaleuca Oil

COUNTERACT  COUGH DROPS ORCHARD CHERRY
menthol lozenge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-131
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL7 mg
Inactive Ingredients
Ingredient NameStrength
ASCORBIC ACID 
CORN SYRUP 
SODIUM ASCORBATE 
SUCROSE 
TEA TREE OIL 
Product Characteristics
Colorred (Purplish Red) Scoreno score
ShapeOVAL (Drops) Size22mm
FlavorCHERRY (Orchard Cherry) Imprint CodeP
Contains    
Packaging
#Item CodePackage Description
1NDC:54473-131-3030 LOZENGE (LOZENGE) 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: 06/2011
 
Melaleuca, 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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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