REFENESEN MUCUS RELIEF- guaifenesin tablet 
Reese Pharmaceutical Co

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 directions

store at 15°-30°C (59°-86°F)

Inactive ingredients

Magnesium Stearate, Microcrystalline Cellulose. Silicon Dioxide, Maltodextrin,  Stearic acid, Povidone K30, Povidone 90F

image of carton label

REFENESEN MUCUS RELIEF 
guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10956-845
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin400 mg
Inactive Ingredients
Ingredient NameStrength
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE K30 (UNII: U725QWY32X)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeOVALSize17mm
FlavorImprint Code PH063
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10956-845-301 in 1 CARTON04/15/2021
130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/15/2021
Labeler - Reese Pharmaceutical Co (004172052)
Registrant - Reese Pharmaceutical Co (004172052)

Revised: 12/2022
Document Id: 44cd160e-b7f7-468b-ab1f-be1c9d1917b3
Set id: 861dffb7-8bf4-4f03-bcc2-ed8a35bc341d
Version: 3
Effective Time: 20221229
 
Reese Pharmaceutical Co