PREFERRED PLUS CHEST CONGESTION RELIEF  - guaifenesin tablet 
Kinray

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.

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Drug Facts


Active ingredient (per tablet)

Guaifenesin  400mg

Purpose

Expectorant

Uses

Warnings

Ask doctor before use if you have

Stop use and ask doctor if

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

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
Document Id: c7ceb971-4f74-43c2-96af-1ae13fc9a98c
Set id: a59ffb1d-9755-461c-8866-e7d0f4fcd430
Version: 1
Effective Time: 20130115
 
Kinray