Premier Value Chest and Sinus Congestion relief

Dosage form: tablet
Ingredients: Guaifenesin 400mg, PHENYLEPHRINE HYDROCHLORIDE 10mg
Labeler: Premier Value
NDC Code: 68016-021

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

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.

PREMIER VALUE CHEST AND SINUS CONGESTION RELIEF 
guaifenesin/phenylephrine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-021
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 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
MAGNESIUM SILICATE 
Product Characteristics
ColorwhiteScore2 pieces
ShapeOVALSize17mm
FlavorImprint CodeRCCGPE;C27
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-021-011 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
1NDC:68016-021-0750 TABLET (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/01/2006
Labeler - Premier Value (101668460)
Registrant - Reese Pharmaceutical Co (004172052)
Establishment
NameAddressID/FEIOperations
Reese Pharmaceutical Co004172052relabel, repack

Revised: 01/2011
 
Premier Value

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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