LEADER iNTENSE COUGH RELIEVER

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 20mg in 5mL, Guaifenesin 300mg in 5mL
Labeler: Cardinal Health
NDC Code: 37205-610

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 per 5ml teaspoon

Dextromethorphan Hydrobromide   20mg   Cough Suppressant
Guaifenesin  300mg  Expectorant

Uses. temporarily relieves cough due to minor throat and bronchial irritation
as may occur with a common cold • helps loosen phlegm (mucus) and thin
bronchial secretions to rid the bronchial passageways of bothersome mucus
• helps make coughs more productive

Do not use if you are now taking a prescription monoamine oxidase (inhiMor~MAIO)

Certain drugs for depression, psychiatric or emotional conditioners or Parkinson's disease

or for 2 weeks after stopping MAIO drug, If you do not know if your prescription drug contains
an MAIO, ask your doctor or pharmacist before using this product

Ask doctor before use if you have

persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysma

cough is accompanied by excessive phlegm (mucous)

Stop use and ask doctor if

Symptoms are accompanied by fever, rash or persistent headache

cough persists for more than 1 week or tends to recur

A persistent cough may be a sign of a serious condition

If pregnant or breastfeeding, ask a health professional before use

Keep out of reach of children, In  case of overdose, get medical help or contact a Poison Center immediately

Directions         
• Adults and children 12 years of age and over:     
take 1 tablet every 4 hours as needed     
• Children 6 to 10 under 12 years of age: take 1/2 tablet every 4 hours as needed
• Children under 6 years of age: consult a doctor     
Do not exceed 6 doses in a 24 hour period or as directed by a doctor
Other information store at 15'- 30' C (59'- 86'F) 

Purpose


Dextromethorphan Hydrobromide      Cough Suppressant

Guaifenesin                                     Expectorant

Cherry Flavor,Citric Acid,Menthol,Polyethylene Glycol,Propylene Glycol,Purified Water,

Sodium Benzoate,Sodium Saccharin,Sorbitol.

LEADER INTENSE COUGH RELIEVER 
dextromethorphan hydrobromide / guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-610
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 5 mL
Guaifenesin (Guaifenesin) Guaifenesin300 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL  
SODIUM BENZOATE 
SORBITOL 
MENTHOL 
PROPYLENE GLYCOL 
SACCHARIN SODIUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:37205-610-011 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
1NDC:37205-610-26120 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/02/2011
Labeler - Cardinal Health (097537435)
Registrant - Reese Pharmaceutical Co (004172052)
Establishment
NameAddressID/FEIOperations
Reese Pharmaceutical Co004172052relabel, repack

Revised: 01/2011
 
Cardinal Health

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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