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 Type HUMAN OTC DRUG Item Code (Source) NDC:61715-012
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 400 mg
Inactive Ingredients
Ingredient Name Strength
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
COPOVIDONE (UNII: D9C330MD8B)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
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:61715-012-50 50 in 1 BOTTLE, PLASTIC
2 NDC:61715-012-01 1 in 1 CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 08/01/2012
Labeler - Kinray (012574513)
Registrant - Reese Pharmaceutical Co (004172052)
Establishment
Name Address ID/FEI Business Operations
Reese Pharmaceutical Co 004172052 relabel(61715-012) , repack(61715-012)
Establishment
Name Address ID/FEI Business Operations
Pharbest 557054835 manufacture(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