REFENESEN CHEST CONGESTION RELIEF - guaifenesin 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

Active ingredient - (per tablet)

Guaifenesin  400mg  Expectoran

Guaifenesin ;                    Expectorant

helps loosen phlegm (mucus) and thin
bronchial secretions to rid the bronchial passageways of bothersome mucus
• helps make coughs more productive

Ask a Doctor before use if you have

Ask doctor before use if you have

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

cough is accompanied by excessive phlegm (mucous)

Keep out of reach of children

In case of overdose,get medical help or contact a poison control

cenetr immediately.

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

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

image of carton

collioidal silicon dioxide, magnesium stearate, microcrystalline cellulose, maltodextrin, povidone, stearic acid.

REFENESEN CHEST CONGESTION RELIEF 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10956-788
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin400 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE, COLLOIDAL (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeOVALSize17mm
FlavorImprint Code PH063
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10956-788-011 in 1 CARTON
1NDC:10956-788-5050 in 1 BOTTLE, PLASTIC
2NDC:10956-788-011 in 1 CARTON
2NDC:10956-788-09100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/23/2003
Labeler - Reese Pharmaceutical Co (004172052)
Registrant - Reese Pharmaceutical Co (004172052)
Establishment
NameAddressID/FEIBusiness Operations
Reese Pharmaceutical Co004172052relabel, repack
Establishment
NameAddressID/FEIBusiness Operations
Pharbest557054835manufacture

Revised: 11/2010
Document Id: 8c2f21fe-dc31-4c4d-9350-f80570271bf2
Set id: 8a172972-d5dd-4c0e-8359-b5fd9edc96d8
Version: 1
Effective Time: 20101101
 
Reese Pharmaceutical Co