FDA.reportPublic FDA data

Desenfriol-ito PLUS

Manufacturer
OPMX LLC
Effective date
2026-09-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-10-06 02:03:59

Label at a glance#

ProductDEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure9 sections

Indications and uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps to loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Dosage and administration

take evey 4 hours do not take more than 6 doses in any 24-hour period measure only with dosing cup provided keep dosing cup with product Age Dose Adults and children 12 years and over 2 teaspoonful (10 mL) Children 6 to under 12 years 1 teaspoonful (5 mL) Children under 6 years Ask a doctor

Storage and handling

Store at 20°-25°C (68° -77°F).  Do not refrigerate. Retain carton for future reference on full labeling

Label contents#

Full prescribing information#

Active Ingredient (in each 5 mL) Purpose

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr USP 10 mg............. Cough suppressant

Guaifenesin, USP 100 mg............................... Expectorant

OTC - PURPOSE SECTION

  • Cough suppressant
  • Expectorant

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps to loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Warnings

WARNINGS SECTION

Warnings

Do not use

OTC - DO NOT USE SECTION

  • Do not useif 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

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. 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. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take evey 4 hours
  • do not take more than 6 doses in any 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product

Age

Dose

Adults and children 12 years and over

2 teaspoonful (10 mL)

Children 6 to under 12 years

1 teaspoonful (5 mL)

Children under 6 years

Ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • Store at 20°-25°C (68° -77°F). 
  • Do not refrigerate.
  • Retain carton for future reference on full labeling

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, cherry flavor, glycerin, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose.

SPL UNCLASSIFIED SECTION

Questions or comments?
Call 619-600-5632

Tamper evident: Do not use if inner seal under cap is broken or missing.

Exclusively distributed by
OPMX
Chula Vista, CA91910
Phone: 619-600-5632


Manufactured in
FDA Registered Facility
In the USA

PRINCIPAL DISPLAY PANEL DESENFRIOLITO

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

desdes

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130810053181799GTIN-13: 0810053181799
EAN-13: 0810053181799
GTIN-12: 810053181799
UPC-A: 810053181799
GTIN storage (14 digits): 00810053181799		_Desenfriolito PLUS 4fl oz 118ml_001.jpg
QR code linkQR Codeopmx.us/_Desenfriolito PLUS 4fl oz 118ml_001.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69729-81269729-812-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SUCRALOSE96K6UQ3ZD4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-10-15full-release2026-06-01 01:39:19

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
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESINDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINOPMX LLC4139bfdc-792f-698a-e063-6394a90ad1af2025-10-15WarningsExact identifier
ndc (package): 69729-812-04
ndc (product): 69729-812
ndc11 (package): 69729081204
spl set id: 4139bfdc-792f-698a-e063-6394a90ad1af

Reported adverse events (FAERS/openFDA)#

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