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CounterAct Cough

Dosage form: syrup
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 10mg in 5mL, GUAIFENESIN 100mg in 5mL
Labeler: Melaleuca, Inc.
NDC Code: 54473-080

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 Content of Label

Active ingredients (in each 5 mL tsp)
Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 100 mg

Purpose
Dextromethorphan HBr, USP 10 mg..........Cough Suppressant
Guaifenesin, USP 100 mg............................Expectorant

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Warnings
Do not use

  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or occurs with fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • do not take more than 6 doses in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age
    age
    dose
    adults and children
    12 years and over
    2 tsp every
    4 hours
    children under 12 years
    do not use

Other information

  • store at 20°-25°C (68°-77°F)

Inactive ingredients  anhydrous citric acid, FD and C red no. 40, flavors, glycerin, high fructose corn syrup, propylene glycol, purified water, saccharin sodium, sodium benzoate

Questions or comments?
1-800-282-3000

DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING

COUNTERACT  COUGH
dextromethorphan hbr. and guaifenesin syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-080
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
FD&C RED NO. 40 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
PROPYLENE GLYCOL 
SACCHARIN SODIUM 
SODIUM BENZOATE 
WATER 
Product Characteristics
Colorred (Orange-red) Score    
ShapeSize
FlavorCHERRY (Wild Cherry) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:54473-080-041 BOTTLE (BOTTLE) in 1 BOX
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/28/2009
Labeler - Melaleuca, Inc. (139760102)

Revised: 03/2011
 
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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