Your browser does not support JavaScript! PREFERRED PLUS CHEST CONGESTION RELIEF (GUAIFENESIN) TABLET [KINRAY]
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PREFERRED PLUS CHEST CONGESTION RELIEF (guaifenesin) tablet
[Kinray]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections


Active ingredient (per tablet)

Guaifenesin  400mg

Purpose

Expectorant

Uses

  • 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 (mucus)

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 breast-feeding, ask a health professional before use.

Keep out of reach of children.

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 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

Other Information

store at 15°-30°C (59°-86°F)

Inactive ingredients

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

image of carton label

PREFERRED PLUS CHEST CONGESTION RELIEF  
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:61715-012
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin) Guaifenesin400 mg
Inactive Ingredients
Ingredient NameStrength
MALTODEXTRIN 
STEARIC ACID 
SILICON DIOXIDE 
COPOVIDONE 
MAGNESIUM STEARATE 
Product Characteristics
ColorwhiteScore2 pieces
ShapeOVALSize17mm
FlavorImprint Code PH063
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61715-012-5050 in 1 BOTTLE, PLASTIC
2NDC:61715-012-011 in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/01/2012
Labeler - Kinray (012574513)
Registrant - Reese Pharmaceutical Co (004172052)
Establishment
NameAddressID/FEIBusiness Operations
Reese Pharmaceutical Co004172052relabel(61715-012), repack(61715-012)
Establishment
NameAddressID/FEIBusiness Operations
Pharbest557054835manufacture(61715-012)

Revised: 1/2013
 
Kinray

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