Refenesen Chest Congestion Relief

Dosage form: tablet
Ingredients: Guaifenesin 400mg
Labeler: Reese Pharmaceutical Co
NDC Code: 10956-788

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 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

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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin400 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE, COLLOIDAL 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
MALTODEXTRIN 
STEARIC ACID 
Product Characteristics
ColorwhiteScore2 pieces
ShapeOVALSize17mm
FlavorImprint CodePH063
Contains    
Packaging
#Item CodePackage Description
1NDC:10956-788-011 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
1NDC:10956-788-5050 TABLET (TABLET) in 1 BOTTLE, PLASTIC
2NDC:10956-788-011 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
2NDC:10956-788-09100 TABLET (TABLET) 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/FEIOperations
Reese Pharmaceutical Co004172052relabel, repack
Establishment
NameAddressID/FEIOperations
Pharbest557054835manufacture

Revised: 11/2010
 
Reese Pharmaceutical Co

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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