REFENESEN CHEST CONGESTION RELIEF PE- guaifenesin/phenylephrine tablet 
REESE PHARMACEUTICAL CO.

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.

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DRUG FACTS

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 stearate,mycocrystalline cellulose,mineral oil,silicon dioxide,sodium lauryl sulfate,stearic acid,titanium oxide and triacetin. May also contain maltodextrin,povidone.

image of carton

REFENESEN CHEST CONGESTION RELIEF  PE
guaifenesin/phenylephrine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10956-381
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin400 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
POVIDONE (UNII: FZ989GH94E)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeOVALSize19mm
FlavorImprint Code PH043
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10956-381-501 in 1 CARTON
150 in 1 BOTTLE, PLASTIC
2NDC:10956-381-091 in 1 CARTON
2100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/25/2014
Labeler - REESE PHARMACEUTICAL CO. (004172052)
Registrant - REESE PHARMACEUTICAL CO. (004172052)
Establishment
NameAddressID/FEIBusiness Operations
REESE PHARMACEUTICAL CO.004172052repack(10956-381) , relabel(10956-381)

Revised: 9/2014
Document Id: 50b1e58e-07f2-43be-8795-9f6126928b8a
Set id: 5667fc64-88b5-4caa-87bb-f08808a1d35c
Version: 1
Effective Time: 20140925
 
REESE PHARMACEUTICAL CO.