RESFRIOL D

Manufacturer
OPMX LLC | Vovantis Laboratories Private Limited
Effective date
2024-01-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:07:57

Label at a glance#

ProductRESFRIOL D
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE
Label structure12 sections

Storage and handling

Other information: Store at room temperature between 20-25°C (68-77ºF); excrusions permitted between 15°C - 30°C (59°F - 86°F) Avoid excessive heat and humidity Tamper Evident: do not use if package or blister unit is open or shows any sing of tampering.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS (in each tablet)

Acetaminophen 500 mg

Chlorpheniramine Maleate 4 mg

Phenylephrine HCl 10 mg

OTC - PURPOSE SECTION

PURPOSE

Pain Reliever/Fever Reducer

Antihistamine

Nasal decongestant

INDICATIONS & USAGE SECTION

Uses:

  • temporarily relieves these symptoms of hay fever or other respiratory allergies:
  • headache
  • sinus congestion & pressure
  • nasal congestion
  • runny nose and sneezing
  • minor aches & pain
  • temporarily relieves these additional symptoms of hay fever:
  • nose or throat itching
  • itchy, watery eyes
  • helps clear nasal passages
  • helps decongest sinus opening and passages

WARNINGS SECTION

Warnings

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

  • more than 6 tablets in 24 hours, which is the maximum daily amount for this product
  • with other drugs contains acetaminophen
  • 3 or more alcoholic drinks every day while using this product.

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

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 doctor promptly

OTC - DO NOT USE SECTION

Do not use:

  • 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
  • to make a child sleepy

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have:

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • glaucoma
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are:

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product:

  • do not use more than directed
  • excitability may occur, especially in children
  • drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

OTC - STOP USE SECTION

Stop use and ask a doctor if:

  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or last more than 3 days
  • redness or swelling is present
  • new symptoms occur

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:Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control 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.

DOSAGE & ADMINISTRATION SECTION

Directions:

  • Do not take more than directed - see overdose warning
  • Swallow whole; do not crush, chew or dissolve
  • Do not exceed 6 tablets per 24 hours
Adults and children 12 years of age & over1 tablet with water every 4-6 hours as needed
Children 4 to 12 years of ageAsk a doctor
Children under 4 years of ageDo not use

STORAGE AND HANDLING SECTION

Other information:

  • Store at room temperature between 20-25°C (68-77ºF); excrusions permitted between 15°C - 30°C (59°F - 86°F)
  • Avoid excessive heat and humidity
  • Tamper Evident: do not use if package or blister unit is open or shows any sing of tampering.

INACTIVE INGREDIENT SECTION

Inactive ingredients: Microcrystalline cellulose, Polyvinylpyrrolidone,Crospovidone, Magnesium stearate, Colloidal silicon dioxide, Purified talc

OTC - QUESTIONS SECTION

Questions or comments?

Call: (619) 600-5632 (Mon-Fri 9am-5pm EST) or www.opmx.us

SPL UNCLASSIFIED SECTION

Exclusively distributed by:

OPMX

San Diego, CA 92154

Phone: 619-600-5632

PRINCIPAL DISPLAY PANEL - 144 TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69729-323-38

RESFRIOL D

Actaminophen 500 mg - Pain reliever/Fever Reducer

Chlorpheniramine Maleate 4 mg - Antihistamine

Phenylephrine HCl 10 mg - Nasal decongestant

Cold/Allergy Relief

To relieve common symptoms of Cold & Allergy such as:

Headache

Sneezing

Nasal Congestion

Itchy, Watery Eyes and Runny Nose ​

​144 Tablets (72 Pouches of 2 tablets)

RD144RD144

PRINCIPAL DISPLAY PANEL - 12 TABLETS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69729-323-37

RESFRIOL D

Actaminophen 500 mg - Pain reliever/Fever Reducer

Chlorpheniramine Maleate 4 mg - Antihistamine

Phenylephrine HCl 10 mg - Nasal decongestant

Cold/Allergy Relief

To relieve common symptoms of Cold & Allergy such as:

Headache

Sneezing

Nasal Congestion

Itchy, Watery Eyes and Runny Nose ​

​12 Tablets (6 Pouches of 2 tablets)

RD12RD12

PRINCIPAL DISPLAY PANEL - 2 Tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69729-323-27

RESFRIOL D

Actaminophen 500 mg - Pain reliever/Fever Reducer

Chlorpheniramine Maleate 4 mg - Antihistamine

Phenylephrine HCl 10 mg - Nasal decongestant

Cold/Allergy Relief

To relieve common symptoms of Cold & Allergy such as:

Headache

Sneezing

Nasal Congestion

Itchy, Watery Eyes and Runny Nose ​

​2 Tablets

RD2RD2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2463332acetaminophen 500 MG / chlorpheniramine maleate 4 MG / phenylephrine HCl 10 MG Oral TabletPSN3
2463332acetaminophen 500 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD3
2463332APAP 500 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral TabletSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-323-27RESFRIOL D2 in 1 POUCHTABLET23
69729-323-37RESFRIOL D6 in 1 CARTONTABLET63
69729-323-37RESFRIOL D2 in 1 POUCHTABLET23
69729-323-38RESFRIOL D2 in 1 POUCHTABLET23
69729-323-38RESFRIOL D72 in 1 CARTONTABLET723

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-323RESFRIOL D (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [OPMX LLC]3Current NDC, 5 package rows20240127_0e9c96b9-41ac-0faf-e063-6294a90a8ab5.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69729-32369729-323-38, 69729-323-37, 69729-323-27

Ingredients#

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

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

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
RESFRIOL DACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLOPMX LLC0e9c96b9-41ac-0faf-e063-6294a90a8ab52024-01-26WarningsExact identifier
ndc (package): 69729-323-27
ndc (package): 69729-323-37
ndc (package): 69729-323-38
ndc (product): 69729-323
ndc11 (package): 69729032337
ndc11 (package): 69729032338
ndc11 (package): 69729032327
spl id: 0fe17f30-ec4a-8f4e-e063-6294a90a1801
spl set id: 0e9c96b9-41ac-0faf-e063-6294a90a8ab5

Reported adverse events (FAERS/openFDA)#

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