FDA.reportPublic FDA data

Resfridol

Manufacturer
Laboratorios Alfa
Effective date
2025-12-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-06-03 17:47:01

Label at a glance#

ProductResfridol Antitussive
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure8 sections

Indications and uses

Temporarily relieves common cold symptoms: cough due to minor throat & bronchial irritation helps loosen phlegm (mucus) and thin bronchial secretions to: drain bronchial tubes make coughs more productive

Dosage and administration

■ only use the dosage cup provided ■ shake well before use ■ do not exceed 6 doses per 24-hour period Age Dose adults and children 12 years and older 20 mL, every 4 hours children 6 to under 12 years 10 mL, every 4 hours children under 6 years do not use

Label contents#

Full prescribing information#

Active ingredients and Purposes

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each 10 mL)Purposes
Dextromethorphan HBr 5 mg ............................................................................

Cough suppressant

Guaifenesin 200 mg...........................................................................................Expectorant

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves common cold symptoms:

  • cough due to minor throat & bronchial irritation
  • helps loosen phlegm (mucus) and thin bronchial secretions to:
  • drain bronchial tubes
  • make coughs more productive

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • 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.

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ a cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

■a cough that is accompanied by excessive phlegm (mucus)

■ a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

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

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

■ only use the dosage cup provided

■ shake well before use

■ do not exceed 6 doses per 24-hour period

Age Dose
adults and children 12 years and older 20 mL, every 4 hours
children 6 to under 12 years 10 mL, every 4 hours
children under 6 years do not use

Other information

OTHER SAFETY INFORMATION

■ store between 68-77°F (20-25°C)

■ do not use if safety seal over cap is torn, broken, or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, FD&C red #40, flavors, sodium benzoate, sorbitol, sucralose, water

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP Resfridol antitusivoPDP Resfridol antitusivo

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
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ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72483-10172483-101-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCRALOSE96K6UQ3ZD4IACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
SODIUM BENZOATEOJ245FE5EUIACT

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
4e5790cb-16b9-d6af-e063-6394a90ab2da2864cc43-2213-c970-e063-6394a90ac61e2026-03-31WarningsExact identifier
spl set id: 2864cc43-2213-c970-e063-6394a90ac61e

Reported adverse events (FAERS/openFDA)#

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