FDA.reportPublic FDA data

Resfridol Antitussive

Manufacturer
Laboratorios Alfa
Effective date
2024-12-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 20:46:29

Label at a glance#

ProductResfridol Antitussive
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure9 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

do not exceed recommended dosage do not exceed 4 doses in a 24-hour period adults & children 12 year of age & over: 1 teaspoonful (10 mL), every 6 hours children 6 to under 12 years of age: 1/2 teaspoonful (5 mL), every 6 hours children under 6 years of age: 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
Guaifenesin 200 mg ............................................................................Expectorant
Dextromethorphan HBr 30 mg..................................................Cough suppressant

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

Ask a doctor or pharmacist before use if you

OTC - ASK DOCTOR SECTION

  • 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.
  • have a persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus)

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.

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. 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 exceed recommended dosage
  • do not exceed 4 doses in a 24-hour period
  • adults & children 12 year of age & over: 1 teaspoonful (10 mL), every 6 hours
  • children 6 to under 12 years of age: 1/2 teaspoonful (5 mL), every 6 hours
  • children under 6 years of age: do not use

Other information

OTHER SAFETY INFORMATION

  • store at room temperature between 77-86°F (25-30°C) TAMPER EVIDENT: Do not use if safety seal over cap is broken, torn, or missing.

Other information

OTHER SAFETY INFORMATION

  • store at room temperature between 77-86°F (25-30°C) TAMPER EVIDENT: Do not use if safety seal over cap is broken, torn, or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

artificial flavors, citric acid, FD&C red no.40, sodium benzoate, sorbitol, sucralose, water

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Resfridol

Antitussive

Syrup

  • Cough Suppressant
  • Expectorant

Dextromethorphan Hbr and Guaifenesin

4 fl oz (120mL)

Resfridol AntitussiveResfridol Antitussive

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72483-100-042024-05-22C16284748780-11030e365-420c-111a-e063-dadaa90a10e2Resfridol Antitussive (OLD) (DA)
72483-100-042024-01-30C16284748780-11030e365-420c-111a-e063-dadaa90a10e2Resfridol Antitussive (OLD) (DA)

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
72483-10072483-100-04

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
2916a959-3c6b-0561-e063-6294a90a6841908f70e0-706b-1234-e053-2a95a90ade842024-12-12WarningsExact identifier
spl id: 2916a959-3c6b-0561-e063-6294a90a6841
spl set id: 908f70e0-706b-1234-e053-2a95a90ade84

Reported adverse events (FAERS/openFDA)#

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