Your browser does not support JavaScript! LEADER CHEST CONGESTION RELIEF PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [CARDINAL HEALTH]
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LEADER CHEST CONGESTION RELIEF PE (guaifenesin/phenylephrine) tablet
[Cardinal Health]


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

Guaifenesin                             400 mg

Phenylephrine HCl                   10 mg

Guaifenesin                               Expectorant

Phenylephrine HCl                   Nasal decongestant

temporarily relieves symptoms associated with a cough ,the common cold,hay fever or other upper respiratory allergies.

helps loosen phlegm;mucus

clear nasal passageways

loosens nasal congestion

drain bronchial tubes

shrinks swollen membranes

clears stuffy nose

makes coughs more productive

do not exceed recommended dosage

Do not use this product if you are now taking a prescription Monoamine Oxidase inhibitor ; MAIO,

certain drugs for depression,psychiatric or emotional conditions, or Parkinsons Disease or for 2 weeks

after stopping the MAIO drug,if you are uncertain whether your prescription contains an MAIO ,

ask a health professional.

ask a doctor before use if you have

heart disease

high blood pressure

thyroid disease

diabetes

excessive phlegm;mucus

difficulty in urination due to an enlarged prostate gland

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

stop use and ask a doctor if

nervousness,dizziness or sleeplessness occurs

symptoms are accompanied by fever,rash,persistent headache or excessive phlegm;mucus.

cough and congestion do not approve within 7 days or tend to recur

these could be signs of a serious condition

ask a health professional before use.

in case of overdose,get medical help or contact a Poison Control Center immediately.

directions

Adults and Children 12 years of age and over take 1 caplet every 4 hours as needed

children 6 to under 12 years of age consult a doctor

do not exceed 6 doses in a 24 hour period or as directed by a doctor.

croscarmellose sodium,hypromellose,lactose,magnesium silicate,

magnesium stearate,maltodextrin,mycocrystalline cellulose,mineral oil,povidone,

silica,sodium lauryl sulfate,stearic acid,titanium oxide and triacetin.

image of carton

LEADER CHEST CONGESTION RELIEF  PE
guaifenesin/phenylephrine tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37205-874
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin400 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
LACTOSE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
MINERAL OIL 
POVIDONE 
MAGNESIUM SILICATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
ColorwhiteScore2 pieces
ShapeOVALSize17mm
FlavorImprint Code RCCGPE;C27
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-874-011 in 1 CARTON
1NDC:37205-874-7150 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/05/2006
Labeler - Cardinal Health (097537435)
Registrant - Reese Pharmaceutical Co (004172052)
Establishment
NameAddressID/FEIBusiness Operations
Reese Pharmaceutical Co004172052relabel, repack

Revised: 1/2011
 
Cardinal Health

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