The Medicine Shoppe Chest Congestion Relief

Manufacturer
Medicine Shoppe International Inc | Reese Pharmaceutical Co | Pharbest
Effective date
2012-09-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:33:07

Label at a glance#

ProductThe Medicine Shoppe Chest Congestion Relief
Active ingredientGuaifenesin
Label structure11 sections

Indications and uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus  helps make coughs more productive

Dosage and administration

Adults and children 12 years of age and over: take 1 tablet every 4 hours as needed Children 6 to 10 under 12 years of age: take 1/2 tablet every 4 hours as needed Children under 6 years of age: consult a doctor     Do not exceed 6 doses in a 24 hour period or as directed by a doctor

Storage and handling

store at 15°-30°C (59°-86°F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION


Active ingredient (per tablet)

Guaifenesin  400mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Uses

INDICATIONS & USAGE SECTION

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus 
  • helps make coughs more productive

Warnings

WARNINGS SECTION

Ask doctor before use if you have

  • persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysema
  • cough is accompanied by excessive phlegm (mucus)

OTC - STOP USE SECTION

Stop use and ask doctor if

  • Symptoms are accompanied by fever, rash or persistent headache
  • cough persists for more than 1 week or tends to recur
A persistent cough may be a sign 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 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 of age and over: take 1 tablet every 4 hours as needed
  • Children 6 to 10 under 12 years of age: take 1/2 tablet every 4 hours as needed
  • Children under 6 years of age: consult a doctor    
Do not exceed 6 doses in a 24 hour period or as directed by a doctor

Other Information

STORAGE AND HANDLING SECTION

store at 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

magnesium stearate, microcrystalline cellulose. May also contain (colloidal) silicon dioxide, (co) povidone, dicalcium phosphate, maltodextrin, sodium starch glycolate, stearic acid.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of carton labelimage of carton label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
359601guaiFENesin 400 MG Oral TabletPSN1
359601guaifenesin 400 MG Oral TabletSCD1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49614-448-012020-01-31C16284748780-19d75b9d0-b3c8-f424-e053-dadaa90a57ceDrug Facts
49614-448-712020-01-31C16284748780-19d75b9d0-b3c8-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49614-448-01The Medicine Shoppe Chest Congestion Relief1 in 1 CARTONTABLET11
49614-448-71The Medicine Shoppe Chest Congestion Relief50 in 1 BOTTLE, PLASTICTABLET501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49614-448THE MEDICINE SHOPPE CHEST CONGESTION RELIEF (GUAIFENESIN) TABLET [MEDICINE SHOPPE INTERNATIONAL INC]1Legacy NDC, 2 package rows20120928_3316b6a5-c0d6-4dd3-9e93-a29d35fc5251.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
GuaifenesinACTIVE INGREDIENT495W7451VQ1
GuaifenesinACTIVE MOIETY495W7451VQ1
COPOVIDONEINACTIVE INGREDIENTD9C330MD8B1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2D1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49614-44849614-448-71, 49614-448-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 145 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED / ORAL3 mgExact identifier — unii candidate
49 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APAEROSOL, FOAM / VAGINAL4 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
26 equally ranked IID candidates
COPOVIDONECOPOVIDONE K25-31D9C330MD8BTABLET, ORALLY DISINTEGRATING / ORAL35 mgExact identifier — unii candidate
16 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii candidate
49 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCAPSULE, EXTENDED RELEASE / ORAL64 mgExact identifier — unii candidate
26 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4PELLET / ORAL34 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, LIQUID FILLED / ORAL106 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4FILM, EXTENDED RELEASE / TRANSDERMAL49 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
COPOVIDONECOPOVIDONE K25-31D9C330MD8BPOWDER, FOR SUSPENSION / ORAL5917 mgExact identifier — unii candidate
16 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION / ORAL200 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30WAFER / ORAL66 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, ORALLY DISINTEGRATING / ORAL187 mgExact identifier — unii candidate
39 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, ORALLY DISINTEGRATING / ORAL12 mgExact identifier — unii candidate
15 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, EXTENDED RELEASE / ORAL168 mgExact identifier — unii candidate
49 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, CHEWABLE / ORAL292 mgExact identifier — unii candidate
15 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30INHALANT / ORAL0.08 mgExact identifier — unii candidate
39 equally ranked IID candidates
COPOVIDONECOPOVIDONE K25-31D9C330MD8BSUSPENSION / ORAL172 mgExact identifier — unii candidate
16 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE / ORAL5000 mgExact identifier — unii candidate
49 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DGRANULE, FOR SUSPENSION / ORAL952 mgExact identifier — unii candidate
15 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / BUCCAL6 mgExact identifier — unii candidate
26 equally ranked IID candidates
COPOVIDONECOPOVIDONE K25-31D9C330MD8BTABLET, FILM COATED, EXTENDED RELEASE / ORAL53 mgExact identifier — unii candidate
16 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii candidate
15 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SYSTEM / TRANSDERMAL35 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SUSPENSION, EXTENDED RELEASE / ORAL71 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TROCHE / ORAL315 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii candidate
49 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / VAGINAL1088 mgExact identifier — unii candidate
26 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CREAM / VAGINAL51 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SUPPOSITORY / RECTAL14 mgExact identifier — unii candidate
49 equally ranked IID candidates
COPOVIDONECOPOVIDONE K25-31D9C330MD8BCAPSULE, DELAYED RELEASE / ORAL199 mgExact identifier — unii candidate
16 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, DELAYED RELEASE / ORAL144 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SOLUTION / ORAL336 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30PELLET / ORAL24 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30DROPS / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SUSPENSION / ORAL400 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER / TOPICAL104 mgExact identifier — unii candidate
39 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DFILM, SOLUBLE / ORAL19 mgExact identifier — unii candidate
15 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, COATED / ORAL5.6 mgExact identifier — unii candidate
15 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30INSERT / VAGINAL69 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4LOZENGE / ORAL120 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FOR SUSPENSION / ORAL220 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / SUBLINGUAL17.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30SYSTEM / INTRAVITREAL0.02 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / DENTAL19 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DSOLUTION / ORAL1451 mgExact identifier — unii candidate
15 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DCAPSULE / ORAL200 mgExact identifier — unii candidate
15 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, DELAYED RELEASE / ORAL80 mgExact identifier — unii candidate
26 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, CHEWABLE, EXTENDED RELEASE / ORAL9 mgExact identifier — unii candidate
39 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, EXTENDED RELEASE / ORAL117 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED PELLETS / ORAL69 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SUSPENSION, EXTENDED RELEASE / ORAL70 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SOLUTION / ORAL1.8 mg/120mlExact identifier — unii candidate
49 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APAEROSOL, FOAM / TOPICAL8 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE / ORAL1190 mgExact identifier — unii candidate
49 equally ranked IID candidates

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
882bb8d4-69fc-4ce8-97d4-e062d6b8ad523316b6a5-c0d6-4dd3-9e93-a29d35fc52512012-09-10WarningsExact identifier
spl id: 882bb8d4-69fc-4ce8-97d4-e062d6b8ad52
spl set id: 3316b6a5-c0d6-4dd3-9e93-a29d35fc5251

Reported adverse events (FAERS/openFDA)#

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