PREMIER VALUE CHEST CONGESTION RELIEF- guaifenesin tablet

Premier Value Chest Congestion Relief by

Drug Labeling and Warnings

Premier Value Chest Congestion Relief by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium, LLC, Reese Pharmaceutical Co. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient - (per tablet)

Guaifenesin  400mg  Expectorant.

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)

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.

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

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PREMIER VALUE CHEST CONGESTION RELIEF 
guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-019
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	400 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
COPOVIDONE (UNII: D9C330MD8B)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	2 pieces
Shape	OVAL	Size	17mm
Flavor		Imprint Code	PH063
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-019-01	1 in 1 CARTON
1		50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	05/04/2009

Labeler - Chain Drug Consortium, LLC (101668460)

Registrant - Reese Pharmaceutical Co (004172052)

Establishment
Name	Address	ID/FEI	Business Operations
Reese Pharmaceutical Co		004172052	relabel(68016-019) , repack(68016-019)