FDA.reportPublic FDA data

DESENFRIOL

Manufacturer
OPMX LLC
Effective date
2026-10-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-10-09 01:01:40

Label at a glance#

ProductDESENFRIOL D
Active ingredientACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves these symptoms of hay fever or other upper respiratory allergies headache sinus congestion & pressure nasal congestion runny nose and sneezing minor aches and pains temporarily relieves these additional symptoms of hay fever: itching of the nose or throat itchy, watery eyes helps clear nasal passages helps decongest sinus openings and passages bloating water-weight gain headache backache muscl...

Dosage and administration

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 & over 1 tablet with water every 4-6 hours as needed Children 4 to 12 years of age Ask a doctor Children under 4 years of age Do not use

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet)

  • Acetaminophen 500 mg
  • Chlorpheniramine Maleate 4 mg
  • Phenylephrine HCl 10 mg

Purpose

OTC - PURPOSE SECTION

  • Pain reliever / Fever reducer
  • Antihistamine
  • Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms of hay fever or other upper respiratory allergies
  • headache
  • sinus congestion & pressure
  • nasal congestion
  • runny nose and sneezing
  • minor aches and pains
  • temporarily relieves these additional symptoms of hay fever:
  • itching of the nose or throat
  • itchy, watery eyes
  • helps clear nasal passages
  • helps decongest sinus openings and passages
  • bloating
  • water-weight gain
  • headache
  • backache
  • muscle aches
  • fatigue

Warnings

WARNINGS SECTION

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

  • more than 6 tablets 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

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 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
  • to make a child sleepy

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Ask a doctor or a pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

  • 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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion 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

These could be signs of a serious condition.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

​Keep out of reach of children

Overdose warning

OVERDOSAGE 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. 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 - 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 & over 1 tablet with water every 4-6 hours as needed
Children 4 to 12 years of age Ask a doctor
Children under 4 years of age Do not use

Other information

OTHER SAFETY INFORMATION

  • Store at room temperature 25°C (77°F); excursions 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 sign of tampering

Questions or comments?

OTC - QUESTIONS SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Microcrystalline cellulose, Polyvinylpyrrolidone, Crospovidone, Magnesium stearate, Colloidal silicon dioxide, Purified talc.

Distributed by

SPL UNCLASSIFIED SECTION

Made for:

RRX San Diego, CA

Exclusively distributed by:

OPMX

Chula Vista, CA 91910

Phone: 619-600-5632

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69729-829-30

DESENFRIOL

Acetaminophen 500 mg Pain Reliever / Fever Reducer - Chlorpheniramine Maleate 4mg Antihistamine

Phenylephrine HCl 10 mg Nasal decongestant

To relieve common symptoms of

Cold & Allergy such as:

Ayuda a Aliviar los Síntomas de Gripe y Alergias como:

Cold/Allergy

Relief

30 Tablets

Headache/Dolor de cabeza

Nasal Congestion / Congestion Nasal

Sneezing / Estornudos

Itchy, Watery eyes and Runny Nose

Comezon, Ojos Llorosos y flujo Nasal

PDP1PDP1

ESPESP

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codeopmx.us/Desenfriol c30 Tablets_001.jpg

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
69729-82969729-829-30

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
CROSPOVIDONE2S7830E561IACT
MAGNESIUM STEARATE70097M6I30IACT
TALC7SEV7J4R1UIACT
POVIDONE K30U725QWY32XIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-06-19monthly-update2026-07-17 21:35:04

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
54a1456d-3019-e0b1-e063-6294a90a8b495489442a-3e34-3b47-e063-6294a90a0d2f2026-06-19WarningsExact identifier
spl set id: 5489442a-3e34-3b47-e063-6294a90a0d2f

Reported adverse events (FAERS/openFDA)#

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