FDA Label for Premier Value Chest Congestion Relief

View Indications, Usage & Precautions

Premier Value Chest Congestion Relief Product Label

The following document was submitted to the FDA by the labeler of this product Chain Drug Consortium, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active ingredient - (per tablet)

Guaifenesin  400mg  Expectorant.


Otc - Purpose



Guaifenesin ;                    Expectorant


Indications & Usage



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


Warnings



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)


Otc - Keep Out Of Reach Of Children



Keep out of reach of children

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

cenetr immediately.


Otc - Stop Use



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


Otc - Pregnancy Or Breast Feeding



If pregnant or breastfeeding, ask a health professional before use


Dosage & Administration



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


Inactive Ingredient



magnesium stearate,microcrystalline cellulose.May also contain ; colloidal ; silicon dioxide, ; co ; povidone ,dicalcium phosphate maltodextrin,sodium starch glycolate,stearic acid.


Package Label.Principal Display Panel




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