ConRx

Manufacturer
Eagle Distributors,Inc.
Effective date
2012-07-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:32:32

Label at a glance#

ProductConRx Cold
Active ingredientAcetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
Label structure11 sections

Indications and uses

for the temporary relief of the following cold symptoms: minor aches and pains headache sore throat nasal congestion cough sinus congestion and pressure helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Dosage and administration

Do not take more than directed Adults and Children 12 years and over Take 2 tablets with water every 6-8 hours as needed Do not take more than 8 tablets in 24 hour Children under 12 years of age Consult a doctor

Storage and handling

Do not use if pouch is torn or damaged. Store between 20-25°C (68-77°F). Avoid excessive heat and humidity. See side panel for lot number and expiration date.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325mg

Dextromethorphan HBr 10 mg

Guaifenesin 200mg

Phenylephrine HCl 5mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/ fever reducer

Cough Suppressant

Expectorant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of the following cold symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • cough
    • sinus congestion and pressure
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 12 tablets in 24 hours, 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: 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 whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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 do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • If you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion or cough gets worse or lasts for more than 7 days
  • fever gets 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 serious conditions.

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

In case of overdose, get medical help or contact a Poison Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Do not take more than directed
Adults and Children 12 years and over
  • Take 2 tablets with water every 6-8 hours as needed
  • Do not take more than 8 tablets in 24 hour
Children under 12 years of ageConsult a doctor

Other Information

STORAGE AND HANDLING SECTION

  • Do not use if pouch is torn or damaged.
  • Store between 20-25°C (68-77°F). Avoid excessive heat and humidity.
  • See side panel for lot number and expiration date.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Colloidal silicon dioxide, Sodium Lauryl Sulphate, Edetaet disodium, dioctyl sodium sulphosuccinate, polyvinyl pyrollidone, gelatin, corn starch', magnesium Stearate, microcrystalline cellulose, polyethylene glycol 6000,Sodium Benzoate ,Sodium Starch Glycolate, Stearic acid, Purified Talc, D & C yellow #10 aluminium lake ,Titanium Dioxide.

SPL UNCLASSIFIED SECTION

Product manufactured for:
Eagle Distributors, Inc.
Los Angeles, CA 90011

PRINCIPAL DISPLAY PANEL - 50 Pouch Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 68737-227-11

Compare to the Active Ingredients in
Tylenol ® Cold
Head Congestion*

ConRx
COLD
SEVERE Sore throat -Cough - Headache

  • Acetaminophen                          Sore throat
  • Dextromethorphan HBr             Cough
  • Guaifenesin                                 Chest Congestion
  • Phenylephrine HCl                     Nasal Congestion

TO OPEN
PUSH IN TAB AND PULL OUT

Compare to the Active Ingredients in
Tylenol
®Cold
Head Congestion*

50 Pouches of 2 Caplets Each

Principal Display Panel - 50 Pouch Carton
Principal Display Panel - 50 Pouch Carton

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
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
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68737-227-112019-11-13C16284748780-197449f38-bab6-f6ea-e053-dbdaa90aa703ConRx Cold

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68737-227-11ConRx Cold2 in 1 POUCHTABLET21
68737-227-11ConRx Cold50 in 1 BOXTABLET501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68737-227CONRX COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [EAGLE DISTRIBUTORS,INC.]1Legacy NDC, 2 package rows20120712_5cef558c-518a-4470-83c3-77f82fc2c4aa.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
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69331
BIS(1-METHYLAMYL) SODIUM SULFOSUCCINATEINACTIVE INGREDIENT772Y8KZU651
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
D&C YELLOW No. 10INACTIVE INGREDIENT35SW5USQ3G1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
GELATININACTIVE INGREDIENT2G86QN327L1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WE1
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5Z1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J1
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 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68737-22768737-227-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 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 9 · 504 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE / ORAL5785 mgExact identifier — unii candidate
22 equally ranked IID candidates
TALCTALC7SEV7J4R1UOINTMENT / TOPICAL74.6 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii candidate
40 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL357 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JGEL / TOPICAL0.05 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, DELAYED RELEASE / ORAL216 mgExact identifier — unii candidate
22 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJPOWDER, FOR SUSPENSION / ORAL34 mgExact identifier — unii candidate
22 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, ORALLY DISINTEGRATING / ORAL6 mgExact identifier — unii candidate
40 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JINSERT / VAGINAL15 mgExact identifier — unii candidate
42 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, COATED PELLETS / ORAL14 mgExact identifier — unii candidate
35 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER / TOPICAL104 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii candidate
49 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLOTION / TOPICAL22 mgExact identifier — unii candidate
77 equally ranked IID candidates
POVIDONE K90POVIDONE K90RDH86HJV5ZSOLUTION / OPHTHALMIC0.3 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
D&C YELLOW No. 10D&C YELLOW NO. 1035SW5USQ3GPOWDER, FOR SUSPENSION / ORAL76 mgExact identifier — unii candidate
31 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSHAMPOO, SUSPENSION / TOPICAL40 %w/vExact identifier — unii candidate
42 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / INTRAVENOUS7 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCAPSULE / ORAL8.5 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, FILM COATED, EXTENDED RELEASE / ORAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / VAGINAL1088 mgExact identifier — unii candidate
26 equally ranked IID candidates
POVIDONE K90POVIDONE K90RDH86HJV5ZCAPSULE / ORAL270 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPASTE / DENTAL1.5 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION / ORAL1600 mgExact identifier — unii candidate
28 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KELIXIR / ORAL1.3 mg/5mlExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET / ORAL46 mgExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, CHEWABLE / ORAL6 mgExact identifier — unii candidate
42 equally ranked IID candidates
D&C YELLOW No. 10D&C YELLOW NO. 1035SW5USQ3GSOLUTION / ORAL8 mgExact identifier — unii candidate
31 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
42 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS6 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCONCENTRATE / ORAL20 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION/ DROPS / ORAL23 mgExact identifier — unii candidate
35 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER / RESPIRATORY (INHALATION)0.13 mgExact identifier — unii candidate
39 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, SUSPENSION / INTRAMUSCULAR1.3 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, COATED / ORAL288 mgExact identifier — unii candidate
44 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SUPPOSITORY / RECTAL14 mgExact identifier — unii candidate
49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL144 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000POLYETHYLENE GLYCOL 600030IQX730WECAPSULE, DELAYED RELEASE PELLETS / ORAL135 mgExact identifier — unii candidate
15 equally ranked IID candidates
D&C YELLOW No. 10D&C YELLOW NO. 1035SW5USQ3GTABLET / SUBLINGUAL0.23 mgExact identifier — unii candidate
31 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933SPONGE / TOPICALNAExact identifier — unii candidate
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCONCENTRATE / ORAL20 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TRANSDERMAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / BUCCAL15 mgExact identifier — unii candidate
35 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, EXTENDED RELEASE / ORAL200 mgExact identifier — unii candidate
26 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE1 mgExact identifier — unii candidate
40 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000POLYETHYLENE GLYCOL 600030IQX730WEINSERT / VAGINAL0.06 mgExact identifier — unii candidate
15 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii candidate
77 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / BUCCAL17.5 mgExact identifier — unii candidate
39 equally ranked IID candidates
GELATINGELATIN2G86QN327LSYSTEM / TOPICAL1050 mgExact identifier — unii candidate
44 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL18 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET / ORAL30 mgExact identifier — unii candidate
35 equally ranked IID candidates
POVIDONE K90POVIDONE K90RDH86HJV5ZCAPSULE, DELAYED RELEASE / ORAL137 mgExact identifier — unii candidate
19 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KOINTMENT / TOPICAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
44 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JPOWDER / VAGINAL3 mgExact identifier — unii candidate
42 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4PELLET / ORAL34 mgExact identifier — unii candidate
49 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, DELAYED RELEASE / ORAL100 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / SUBLINGUAL10 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
027ea3a1-9733-468e-9ae5-872c113813095cef558c-518a-4470-83c3-77f82fc2c4aa2012-07-10WarningsExact identifier
spl id: 027ea3a1-9733-468e-9ae5-872c11381309
spl set id: 5cef558c-518a-4470-83c3-77f82fc2c4aa

Reported adverse events (FAERS/openFDA)#

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