FDA.reportPublic FDA data

Viro-Flu AM 50 softgels

Manufacturer
OPMX LLC
Effective date
2026-10-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-10-13 04:03:59

Label at a glance#

ProductViro-Flu AM
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE
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 and pains fever

Dosage and administration

take only as directed do not exceed 6 doses per 24 hours adults & children 12 years & over 2 softgels with water every 4 hrs children 4 to under 12 years ask a doctor children under 4 years do not use

Label contents#

Full prescribing information#

Active ingredients (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg

Purpose

OTC - PURPOSE SECTION

Purpose

  • Analgesic
  • Cough suppressant
  • Nasal 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 and pains
  • fever

Warnings

WARNINGS SECTION

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

  • more than 6 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: 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, 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

Ask a doctor or pharmacist before use if you are:

OTC - ASK DOCTOR/PHARMACIST SECTION

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 nervous, 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 symptoms occur
  • cough comes back, or occurs with rash or headache that lasts
    These could be signs of a serious condition.

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. Quick 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

  • take only as directed
  • do not exceed 6 doses per 24 hours
adults & children 12 years & over2 softgels with water every 4 hrs
children 4 to under 12 yearsask a doctor
children under 4 yearsdo not use

Other information

OTHER SAFETY INFORMATION

  • 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, titanium dioxide.

Questions?

OTC - QUESTIONS SECTION

Questions? Call toll free 619-600-5632 Monday through Friday 9AM - 5PM EST.

Distributed by

SPL UNCLASSIFIED SECTION

Made for:

RRX

San Diego, CA 92154

Exclusively distributed by:

OPMX

Chula Vista, CA 91910

Phone: 619-600-5632

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FORMULA WITH PHENYLEPHRINE / FORMULA CON FENILEFRINA

NDC 69729-831-50

Daytime Formula

Viro-Flu a.m. Gel Caps

25 Pouches (25 packs of 2 softgels)

50 softgels

More than 8 hours of relief!

¡Alivio por mas de 8 horas!

NON DROWSY

FORMULA

NO PRODUCE SUENO

PDPPDP

POUCHPOUCH

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130810053181874GTIN-13: 0810053181874
EAN-13: 0810053181874
GTIN-12: 810053181874
UPC-A: 810053181874
GTIN storage (14 digits): 00810053181874		VIRO FLU AM POUCH.jpg
QR code linkQR Codeopmx.us/VIRO FLU PDP.jpg

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
69729-83169729-831-50, 69729-831-02

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32026-07-15daily-update2026-07-18 05:11:06
22026-07-06weekly-update2026-07-17 21:43:32
12026-06-25monthly-update2026-07-17 21:37:11

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
56a7f86e-4f79-0826-e063-6394a90ade6d551c957a-2e44-2b17-e063-6394a90a52952026-07-15WarningsExact identifier
spl set id: 551c957a-2e44-2b17-e063-6394a90a5295

Reported adverse events (FAERS/openFDA)#

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