GNP MUCUS RELIEF PE- guaifenesin/phenylephrine tablet 
AmerisourceBergen Drug Corp

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   400 mg

Phenylephrine HCl  10 mg

Purpose

Guaifenesin.......................Expectorant

Phenylephrine HCl..............Nasal decongestant

Uses

Temporarily relieves symptoms associated with a cough ,the common cold,hay fever or other upper respiratory allergies.

Warnings

Do not exceed recommended dosage

Do not use

This product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression,
psychiatric or emotional conditions, or Parkinson’s Disease), or for 2 weeks after stopping the
MAOI drug. If you are uncertain whether your prescription drug contains an MAOI, ask a health
professional.

Ask a doctor before use if you have

Stop use and ask a doctor if

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health
professional before use.

Keep out of the 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.

Inactive ingredients

croscarmellose sodium, Hypromellose, lactose, magnesium silicate, magnesium stearate maltodextrin, microcrystalline cellulose, mineral oil, povidone, silicon dioxide, sodium lauryl sulfate, stearic acid, titanium dioxide, triacetin

Carton Panel

image of carton

image description

GNP MUCUS RELIEF  PE
guaifenesin/phenylephrine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-700
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin400 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LACTOSE (UNII: J2B2A4N98G)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
POVIDONE (UNII: FZ989GH94E)  
MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeOVALSize18mm
FlavorImprint Code PH043
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46122-700-711 in 1 CARTON01/13/2022
150 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/13/2022
Labeler - AmerisourceBergen Drug Corp (007914906)
Registrant - Reese Pharmaceutical Co (004172052)
Establishment
NameAddressID/FEIBusiness Operations
Pharbest557054835manufacture(46122-700)

Revised: 7/2023
Document Id: b8ceed18-8a8c-41e8-94bb-bf555d0fe20f
Set id: 63932e68-b09d-4500-bc1d-cfb2c267df1c
Version: 3
Effective Time: 20230714
 
AmerisourceBergen Drug Corp