FDA.reportPublic FDA data

Desresfriol-DX Softgels

Manufacturer
OPMX LLC. | SOFTECH PHARMA PRIVATE LIMITED
Effective date
2024-04-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:10:45

Label at a glance#

ProductDesresfriol-DX Softgels
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

Temporarily relieves common cold/flu symptoms: Nasal congestion Cough due to minor throat & bronchial irritation Sore throat Headache Minor aches & pains Fever

Dosage and administration

Take only as directed. Do not exceed 4 doses per 24 hrs. Adults & children 12 yrs & over 2 softgels with water every 4 hrs Children 4 to under 12 yrs Ask a doctor Children under 4 yrs Do not use

Storage and handling

Store at room temperature

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each Softgel)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Phenylephrine HCl 5 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves common cold/flu symptoms:

  • Nasal congestion
  • Cough due to minor throat & bronchial irritation
  • Sore throat
  • Headache
  • Minor aches & pains
  • Fever

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 daily while using this product

Allergy alert

SPL UNCLASSIFIED SECTION

Acetaminophen may cause severe skin reactions. Symtoms may include:

  • Skin reddening blisters
  • Rash
  • If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning

SPL UNCLASSIFIED SECTION

If sore throat is severe, lasts 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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • Liver disease
  • Heart 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, chronic bronchitis or emphysema.

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product,

OTC - WHEN USING SECTION

do not use more than directed.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • You get nervouz, dizzy or sleepless.
  • Symptoms get worse or last more than 5 days (children) or 7 days (adults).
  • Fever gets worse or lasts more than 3 days.
  • Redness or swelling is present.
  • New symtoms occur.
  • Cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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 as well for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Take only as directed.
  • Do not exceed 4 doses per 24 hrs.
Adults & children 12 yrs & over2 softgels with water every 4 hrs
Children 4 to under 12 yrsAsk a doctor
Children under 4 yrsDo not use

Other information

STORAGE AND HANDLING SECTION

Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, titanium dioxide.

Questions?

OTC - QUESTIONS SECTION

Call to free 619-600-5632 Monday throughFriday 9AM - 5PM EST

SPL UNCLASSIFIED SECTION

Made for:

RRX

Exclusively distributed by:

OPMX

Chula Vista, CA 91910

Phone: 619-600-5632

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69729-121-10

Desresfriol-DX

Acetaminophen, Dextromethorphan, Phenylephrine

Flu&Cough

Gripe y Tos

Dolor de cuerpo/Body Aches

Fiebre/Fever

Dolor de Garganta/Sore Throat

Congestion Nasal/Nasal Congestion

Tos/Cough

10 Cápsulas Blandas de Gel/Softgels

Desrefriol DayTime 10 SoftgelDesrefriol DayTime 10 Softgel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSN2
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCD2
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSY2

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-121-10Desresfriol-DX Softgels1 in 1 CARTONCAPSULE, LIQUID FILLED12
69729-121-10Desresfriol-DX Softgels10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-121DESRESFRIOL-DX SOFTGELS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [OPMX LLC.]2Current NDC, 2 package rows20240407_ff5e0e0f-bfd2-b02b-e053-6394a90afe8a.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69729-12169729-121-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C YELLOW NO. 6H77VEI93A8IACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
ACETAMINOPHEN362O9ITL9DACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

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
Desresfriol-DX SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEOPMX LLC.ff5e0e0f-bfd2-b02b-e053-6394a90afe8a2024-04-05WarningsExact identifier
ndc (package): 69729-121-10
ndc (product): 69729-121
ndc11 (package): 69729012110
spl id: 155f7122-feb9-c81f-e063-6294a90ab72d
spl set id: ff5e0e0f-bfd2-b02b-e053-6394a90afe8a

Reported adverse events (FAERS/openFDA)#

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