FDA.reportPublic FDA data

GNP Mucus Relief

Manufacturer
AmerisourceBergen Drug Corp | Reese Pharmaceutical Co | Pharbest
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:44:40

Label at a glance#

ProductGNP Mucus Relief PE
Active ingredientGuaifenesin, PHENYLEPHRINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

Temporarily relieves symptoms associated with a cough ,the common cold,hay fever or other upper respiratory allergies. helps loosen phlegm (mucus) clear nasal passageways loosens nasal congestion drain bronchial tubes shrinks swollen membranes clears stuffy nose makes coughs more productive thin bronchial secretions

Dosage and administration

adults and children 12 years and over: take 1 caplet every 4 hours as needed children 6 to under 12 years: take 1/2 caplet every 4 hours as needed children under 6 years: consult a doctor Do not exceed 6 doses in a 24 hour period or as directed by a doctor.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient - (per tablet)

Guaifenesin   400 mg

Phenylephrine HCl  10 mg

Purpose

OTC - PURPOSE SECTION

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

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

Uses

INDICATIONS & USAGE SECTION

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

  • helps loosen phlegm (mucus)
  • clear nasal passageways
  • loosens nasal congestion
  • drain bronchial tubes
  • shrinks swollen membranes
  • clears stuffy nose
  • makes coughs more productive
  • thin bronchial secretions

Warnings

WARNINGS SECTION

Do not exceed recommended dosage

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • excessive phlegm;mucus
  • difficulty in urination due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking,asthma,chronic bronchitis or emphysema

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness or sleeplessness occurs
  • symptoms are accompanied by fever, rash, persistent headache or excessive phlegm (mucus)
  • cough and congestion do not improve within 7 days or tend to recur.

These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison
Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and over: take 1 caplet every 4 hours as needed
  • children 6 to under 12 years: take 1/2 caplet every 4 hours as needed
  • children under 6 years: consult a doctor

Do not exceed 6 doses in a 24 hour period or as directed by a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of cartonimage of carton

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1304111guaiFENesin 400 MG / phenylephrine HCl 10 MG Oral TabletPSN4
1304111guaifenesin 400 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-700-71GNP Mucus ReliefPE1 in 1 CARTONTABLET14
46122-700-71GNP Mucus ReliefPE50 in 1 BOTTLETABLET504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-700GNP MUCUS RELIEF PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [AMERISOURCEBERGEN DRUG CORP]4Current NDC, Legacy NDC, 2 package rows20241220_63932e68-b09d-4500-bc1d-cfb2c267df1c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-700-71EA - Each46122-700ef092673-106d-4a07-876b-e9f0f8df1aab12023-04-07

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46122-70046122-700-71

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
Guaifenesin495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
LACTOSEJ2B2A4N98GIACT
MALTODEXTRIN7CVR7L4A2DIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MINERAL OILT5L8T28FGPIACT
POVIDONEFZ989GH94EIACT
MAGNESIUM SILICATE9B9691B2N9IACT
MAGNESIUM STEARATE70097M6I30IACT
SODIUM LAURYL SULFATE368GB5141JIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
SILICON DIOXIDEETJ7Z6XBU4IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GNP Mucus Relief PEGUAIFENESIN/PHENYLEPHRINEAmerisourceBergen Drug Corp63932e68-b09d-4500-bc1d-cfb2c267df1c2024-12-18WarningsExact identifier
ndc (package): 46122-700-71
ndc (product): 46122-700
ndc11 (package): 46122070071
spl id: d97803b2-8d2a-42a1-9864-581cf86f698c
spl set id: 63932e68-b09d-4500-bc1d-cfb2c267df1c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.