FDA.reportPublic FDA data

Viro-Flu PM 50 softgels

Manufacturer
OPMX LLC | OCEAN HEALTHCARE PVT LTD
Effective date
2026-07-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
weekly-update
Hydrated at
2026-07-17 21:43:31

Label at a glance#

ProductViro-Flu PM
Active ingredientACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure10 sections

Indications and uses

Temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches and pains fever runny nose and sneezing

Dosage and administration

take only as directed do not exceed 4 doses per 24 hours adults & children 12 years & over 2 softgels with water every 6 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, Doxylamine Succinate 6.25 mg

Purpose

OTC - PURPOSE SECTION

Purpose

  • Analgesic
  • Cough suppressant
  • Antihistamine

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves common cold/flu symptoms:

  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing

Warnings

WARNINGS SECTION

Liver warning: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: 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
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are:

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking sedatives or tranquilizers
  • Taking the blood thinning drug warfarin.

When using this product

OTC - WHEN USING SECTION

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, & tranquilizers may increase drowsiness

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • cough comes back or occurs with rash or headache that lasts
  • new symptoms occur
    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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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 4 doses per 24 hours
adults & children 12 years & over2 softgels with water every 6 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

D&C Yellow No.10, FD&C Blue No. 1, 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

NDC 69729-832-50

Viro-Flu p.m. Gel Caps

25 Pouches / Sobres

50 softgels / Capsulas de gelatina blanda

More than 8 hours of relief!

¡Alivio por mas de 8 horas!

Acetaminophen 325 mg / Dextromethorphan HBr 10 mg / Doxylamine succinate 6.25 mg


Temporarily relieves symptoms due to:
Alivia temporalmente los síntomas
debidos a:
Fever / Fiebre
Runny Nose & Sneezing / Secreción Nasal y Estornudos
Sore Throat / Dolor de Garganta
Headache and Body Ache / Dolor de Cabeza y Dolores Corporales
Cough / Tos
Flu / Gripe

PDP1PDP1

POUCHPOUCH

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130810053181898GTIN-13: 0810053181898
EAN-13: 0810053181898
GTIN-12: 810053181898
UPC-A: 810053181898
GTIN storage (14 digits): 00810053181898		VIRO FLU PM POUCH.jpg
QR code linkQR Codeopmx.us/Viro Flu PM Carton Final.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
69729-83269729-832-50

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
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT
POVIDONEFZ989GH94EIACT
WATER059QF0KO0RIACT
GELATIN2G86QN327LIACT
ACETAMINOPHEN362O9ITL9DACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB

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
56947cb7-be18-6809-e063-6394a90aa13455f8484f-6a94-01f3-e063-6294a90a68062026-07-14WarningsExact identifier
spl set id: 55f8484f-6a94-01f3-e063-6294a90a6806

Reported adverse events (FAERS/openFDA)#

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