Otc - Active Ingredient
Guaifenesin 400 mg
Phenylephrine HCl 10 mg
Premier Value Chest And Sinus Congestion Relief
FDA Label NDC 68016-021
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Consortium, Llc for the product Premier Value Chest And Sinus Congestion Relief (NDC 68016-021). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Guaifenesin Expectorant
Phenylephrine HCl Nasal decongestant
Indications & Usage
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
Warnings
do not exceed recommended dosage
Otc - Do Not Use
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.
Otc - Ask Doctor
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
Otc - Stop Use
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
Otc - Pregnancy Or Breast Feeding
ask a health professional before use.
Otc - Keep Out Of Reach Of Children
in case of overdose,get medical help or contact a Poison Control Center immediately.
Dosage & Administration
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.
Inactive Ingredient
croscarmellose sodium,hypromellose,lactose,magnesium silicate,
magnesium stearate,maltodextrin,mycocrystalline cellulose,mineral oil,povidone,
silica,sodium lauryl sulfate,stearic acid,titanium oxide and triacetin.
Package Label.Principal Display Panel
Image Of Carton (Premvalrpe.jp0001)
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