FDA.reportPublic FDA data

ConRX DayTime

Manufacturer
Eagle Distributors,Inc
Effective date
2014-01-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:38:16

Label at a glance#

ProductConRX DayTime
Active ingredientPhenylephrine Hydrochloride, Acetaminophen, DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin
Label structure9 sections

Indications and uses

temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation minor aches & pains headache fever sore throat reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersom...

Dosage and administration

take only as directed - see Overdose warning do no exceed 4 doses per 24 hours   adult and children 12 years and over, 2 Caplets with water every 4 hours   children 4 to under 12 years, ask a doctor   children under 4 years, do not use

Storage and handling

each caplet contains: sodium 4 mg store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each CaplePurpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestan

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • sinus congestion & pressure
  • cough due to minor
  • throat & bronchial irritation
  • minor aches & pains
  • headache
  • fever
  • sore throat
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4 doses in 24 hrs, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Sore throat warning

SPL UNCLASSIFIED SECTION

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure wheather a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are now taking 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 do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

OTC - WHEN USING SECTION

When using this product

  • do not use more than directed

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with rash or headache that lasts. 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 reach of children.

Overdose warning

SPL UNCLASSIFIED SECTION

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only as directed - see Overdose warning
  • do no exceed 4 doses per 24 hours
    • adult and children 12 years and over, 2 Caplets with water every 4 hours
    • children 4 to under 12 years, ask a doctor
    • children under 4 years, do not use

Other information

STORAGE AND HANDLING SECTION

  • each caplet contains: sodium 4 mg
  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

sodium starch glycolate, croscarmellose sodium, FD&C Yellow No. 6, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidones, corn starch, gelatin, magnesium stearate, silicon dioxide, stearic acid, talc, titanium dioxide, sodium benzoate hydroxypropylmethyl cellulose

Questions?

OTC - QUESTIONS SECTION

1-855-619-7900

PRINCIPAL DISPLAY PANEL - 50 x 2 Caplet Pouch Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the Active Ingredients in
DayQuil®
SEVERE

ConRx®

DayTime
COLD & FLU

Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr, Guaifenesin

MAX
STRENGTH

Non-Drowsy

  • Headache, Fever, Sore Throat, Minor Aches & Pains
  • Nasal/Sinus Congestion & Sinus Pressure
  • Cough
  • Chest Congestion

2 Caplets Each Pouch

TO OPEN
PUSH IN TAB AND PULL OUT

Compare to the Active Ingredients in
DayQuil®
SEVERE

2 Caplets Each Pouch

Principal Display Panel - 50 x 2 Caplet Pouch Box
Principal Display Panel - 50 x 2 Caplet Pouch Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1110988acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral TabletPSN1
1110988acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD1
1110988APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral TabletSY1

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68737-238-222019-11-27C16284748780-19855e2a2-45f3-60a7-e053-dbdaa90a05bdConRX ® DayTime

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68737-238-22ConRX DayTime2 in 1 POUCHTABLET21
68737-238-22ConRX DayTime50 in 1 BOXTABLET501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68737-238CONRX DAYTIME (PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN) TABLET [EAGLE DISTRIBUTORS,INC]1Legacy NDC, 2 package rows20140131_edb1096e-30fa-46da-a498-d90fd5e05287.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9D1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYH1
GuaifenesinACTIVE INGREDIENT495W7451VQ1
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJ1
AcetaminophenACTIVE MOIETY362O9ITL9D1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTS1
GuaifenesinACTIVE MOIETY495W7451VQ1
PhenylephrineACTIVE MOIETY1WS297W6MV1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61U1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH481
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A81
GelatinINACTIVE INGREDIENT2G86QN327L1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO1
Magnesium StearateINACTIVE INGREDIENT70097M6I301
MaltodextrinINACTIVE INGREDIENT7CVR7L4A2D1
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1A1
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8H1
Polyvinyl AlcoholINACTIVE INGREDIENT532B59J9901
PovidonesINACTIVE INGREDIENTFZ989GH94E1
Silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU41
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EU1
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6B1
Starch, CornINACTIVE INGREDIENTO8232NY3SJ1
Stearic AcidINACTIVE INGREDIENT4ELV7Z65AP1
TalcINACTIVE INGREDIENT7SEV7J4R1U1
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JP1

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68737-23868737-238-22

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
Phenylephrine Hydrochloride04JA59TNSJACTIB
Acetaminophen362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
Guaifenesin495W7451VQACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
Maltodextrin7CVR7L4A2DIACT
Cellulose, MicrocrystallineOP1R32D61UIACT
Polysorbate 806OZP39ZG8HIACT
PovidonesFZ989GH94EIACT
Polyethylene Glycols3WJQ0SDW1AIACT
Silicon dioxideETJ7Z6XBU4IACT
Talc7SEV7J4R1UIACT
Titanium dioxide15FIX9V2JPIACT
Stearic Acid4ELV7Z65APIACT
Polyvinyl Alcohol532B59J990IACT
Starch, CornO8232NY3SJIACT
Gelatin2G86QN327LIACT
Magnesium Stearate70097M6I30IACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
Sodium BenzoateOJ245FE5EUIACT
HYPROMELLOSES3NXW29V3WOIACT

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 10 · 541 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Polysorbate 80POLYSORBATE 806OZP39ZG8HSOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, FILM COATED / ORAL1 mgExact identifier — unii candidate
34 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30POWDER / RESPIRATORY (INHALATION)0.13 mgExact identifier — unii candidate
39 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / SUBLINGUAL1 mgExact identifier — unii candidate
34 equally ranked IID candidates
MaltodextrinMALTODEXTRIN7CVR7L4A2DTABLET, EXTENDED RELEASE / ORAL3239 mgExact identifier — unii candidate
15 equally ranked IID candidates
Polysorbate 80POLYSORBATE 806OZP39ZG8HINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS53 mgExact identifier — unii candidate
78 equally ranked IID candidates
PovidonesPOVIDONEFZ989GH94ECAPSULE, EXTENDED RELEASE / ORAL56 mgExact identifier — unii candidate
30 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOCAPSULE, DELAYED RELEASE / ORAL105 mgExact identifier — unii candidate
27 equally ranked IID candidates
Silicon dioxideSILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
Polysorbate 80POLYSORBATE 806OZP39ZG8HDROPS / AURICULAR (OTIC)0.02 %w/wExact identifier — unii candidate
78 equally ranked IID candidates
Starch, CornSTARCH, CORNO8232NY3SJPASTILLE / ORALNAExact identifier — unii candidate
22 equally ranked IID candidates
Polyvinyl AlcoholPOLYVINYL ALCOHOL532B59J990SOLUTION/ DROPS / OPHTHALMIC1.4 %w/vExact identifier — unii candidate
17 equally ranked IID candidates
Silicon dioxideSILICON DIOXIDEETJ7Z6XBU4INSERT / VAGINAL8 mgExact identifier — unii candidate
49 equally ranked IID candidates
Polysorbate 80POLYSORBATE 806OZP39ZG8HSPRAY, METERED / NASAL0.1 mg/1mlExact identifier — unii candidate
78 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii candidate
27 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8LIQUID / ORAL0.2 mg/1mlExact identifier — unii candidate
34 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii candidate
27 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APEMULSION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, DELAYED RELEASE / ORAL349 mgExact identifier — unii candidate
35 equally ranked IID candidates
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET / SUBLINGUAL10 mgExact identifier — unii candidate
22 equally ranked IID candidates
Titanium dioxideTITANIUM DIOXIDE15FIX9V2JPSUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE1 mgExact identifier — unii candidate
40 equally ranked IID candidates
GelatinGELATIN2G86QN327LSOLUTION / INTRAVENOUS34.8 mgExact identifier — unii candidate
44 equally ranked IID candidates
Polyvinyl AlcoholPOLYVINYL ALCOHOL532B59J990TABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii candidate
17 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UPOWDER, FOR SUSPENSION / ORAL4441 mgExact identifier — unii candidate
28 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APCREAM / VAGINAL1088 mgExact identifier — unii candidate
26 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / BUCCAL1 mgExact identifier — unii candidate
34 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSUSPENSION / OPHTHALMIC0.5 %w/wExact identifier — unii candidate
27 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8MOUTHWASH / BUCCAL0.01 mg/1mlExact identifier — unii candidate
34 equally ranked IID candidates
Silicon dioxideSILICON DIOXIDEETJ7Z6XBU4FILM, SOLUBLE / ORAL2 mgExact identifier — unii candidate
49 equally ranked IID candidates
Polyvinyl AlcoholPOLYVINYL ALCOHOL532B59J990SYSTEM / TOPICAL420 mgExact identifier — unii candidate
17 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, EXTENDED RELEASE / ORAL4.59 mgExact identifier — unii candidate
34 equally ranked IID candidates
Polysorbate 80POLYSORBATE 806OZP39ZG8HCREAM / TOPICAL20 mgExact identifier — unii candidate
78 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
34 equally ranked IID candidates
Polysorbate 80POLYSORBATE 806OZP39ZG8HSOLUTION / OPHTHALMIC8 mgExact identifier — unii candidate
78 equally ranked IID candidates
Polysorbate 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / SOFT TISSUE4 mgExact identifier — unii candidate
78 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOCAPSULE, COATED PELLETS / ORAL3.32 mgExact identifier — unii candidate
27 equally ranked IID candidates
Polyvinyl AlcoholPOLYVINYL ALCOHOL532B59J990SUSPENSION/ DROPS / OPHTHALMIC1.4 %w/vExact identifier — unii candidate
17 equally ranked IID candidates
Titanium dioxideTITANIUM DIOXIDE15FIX9V2JPLOTION / TOPICALNAExact identifier — unii candidate
40 equally ranked IID candidates
Polysorbate 80POLYSORBATE 806OZP39ZG8HTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL34 mgExact identifier — unii candidate
78 equally ranked IID candidates
Starch, CornSTARCH, CORNO8232NY3SJTABLET, DELAYED RELEASE / ORAL713 mgExact identifier — unii candidate
22 equally ranked IID candidates
Starch, CornSTARCH, CORNO8232NY3SJINSERT / VAGINAL147 mgExact identifier — unii candidate
22 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, COATED / ORAL320.75 mgExact identifier — unii candidate
35 equally ranked IID candidates
Titanium dioxideTITANIUM DIOXIDE15FIX9V2JPPOWDER / RESPIRATORY (INHALATION)2 mgExact identifier — unii candidate
40 equally ranked IID candidates
TalcTALC7SEV7J4R1UTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL357 mgExact identifier — unii candidate
35 equally ranked IID candidates
Polyvinyl AlcoholPOLYVINYL ALCOHOL532B59J990TABLET, COATED / ORAL0.7 mgExact identifier — unii candidate
17 equally ranked IID candidates
Starch, CornSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii candidate
22 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8POWDER, FOR SOLUTION / ORAL40 mgExact identifier — unii candidate
34 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APPELLET / SUBCUTANEOUS0.97 mgExact identifier — unii candidate
26 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUGEL / DENTAL0.08 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
Silicon dioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE, LIQUID FILLED / ORAL106 mgExact identifier — unii candidate
49 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED, EXTENDED RELEASE / ORAL615 mgExact identifier — unii candidate
28 equally ranked IID candidates
Titanium dioxideTITANIUM DIOXIDE15FIX9V2JPPOWDER / ORAL2 mgExact identifier — unii candidate
40 equally ranked IID candidates
MaltodextrinMALTODEXTRIN7CVR7L4A2DFILM, SOLUBLE / ORAL19 mgExact identifier — unii candidate
15 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSYRUP / ORAL250 mgExact identifier — unii candidate
27 equally ranked IID candidates
Silicon dioxideSILICON DIOXIDEETJ7Z6XBU4DROPS / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE, DELAYED RELEASE / ORAL789.6 mgExact identifier — unii candidate
28 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL47 mgExact identifier — unii candidate
39 equally ranked IID candidates
PovidonesPOVIDONEFZ989GH94ECAPSULE, DELAYED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8POWDER, FOR SUSPENSION / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
Silicon dioxideSILICON DIOXIDEETJ7Z6XBU4POWDER / RESPIRATORY (INHALATION)NAExact 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
13b8d214-6167-49c7-bca3-acb3ea7515a5edb1096e-30fa-46da-a498-d90fd5e052872014-01-21WarningsExact identifier
spl id: 13b8d214-6167-49c7-bca3-acb3ea7515a5
spl set id: edb1096e-30fa-46da-a498-d90fd5e05287

Reported adverse events (FAERS/openFDA)#

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