Indications and uses
Temporarily reliever common cold/flu symptoms: Cough due to minor throat & bronchial irritation Sore throat Headache Minor aches and pains Fever
Viro-Flu AM Relief w/10 RED SoftTablets
- Manufacturer
- OPMX LLC
- Effective date
- 2026-09-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- daily-update
- Hydrated at
- 2026-10-06 02:03:15
Label at a glance#
ProductViro-Flu AM Relief
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN
Label structure9 sections
Dosage and administration
Take only as directed. Do not exceed 4 doses per 24 hours. Adults & children 12 yrs & over 2 softgels with water every 4 hrs Children 4 o under 12 yrs Ask a doctor Children under 4 yrs Do not use
Contacts and useful links#
Label contents#
Full prescribing information#
Drug Facts
Active ingredients (in each Softgel)
- Acetaminophen 325 mg
- Dextromethorphan HBr 10 mg
Purpose
- Pain reliever
- Fever reducer
Uses
Temporarily reliever common cold/flu symptoms:
- Cough due to minor throat & bronchial irritation
- Sore throat
- Headache
- Minor aches and pains
- Fever
Warnings
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 allert: 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.
Do not use
- 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
- 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 doctorpr pharmacist before use if you are:
Taking the blood thinning drug warfarin.
When using this product,
do not use more than directed.
Stop use and ask a doctor if
- You get nervous, dizzy or sleepless.
- Symtoms 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
Keep out of reach of children.
If pregnant or breast-feeding,
ask a health professional before use.
Overdose warning:
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 symtoms.
Directions
- Take only as directed.
- Do not exceed 4 doses per 24 hours.
| Adults & children 12 yrs & over | 2 softgels with water every 4 hrs |
| Children 4 o under 12 yrs | Ask a doctor |
| Children under 4 yrs | Do not use |
Other information
- Store at room temperature.
Inactive ingredients:
FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, titanium dioxide.
Questions?
Call toll free 619-600-5632 Monday through Friday 9AM - 5PM EST
SPL UNCLASSIFIED SECTION
Exclusively distributed by:
OPMX
Chula Vista, CA 91910
Phone: 619-600-5632
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 69729-056-10
Daytime Formula
Viro-Flu
a.m. Gel Caps
10 Soft Gels
Fiebre/ Fever
Resfriado/ Cold
Gripe/ Flu
Tos/ Cough
Ardor de Garganta/ Sore Throat
Dolor de cabeza y Cuerpo Cortado/ Headache and Body Ache
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0810053180136 | GTIN-13: 0810053180136 EAN-13: 0810053180136 GTIN-12: 810053180136 UPC-A: 810053180136 GTIN storage (14 digits): 00810053180136 | Viroflu am 10 soft gel_001.jpg |
| QR code link | QR Code |  opmx.us/ | Viroflu am 10 soft gel_001.jpg |
DailyMed Product Concepts#
Products#
Every source-derived product name is available through these pages.
- Viro-Flu AM Relief
- Acetaminophen, Dextromethorphan Hydrobromide
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- ACETAMINOPHEN
- PROPYLENE GLYCOL
- SORBITOL
- POLYETHYLENE GLYCOL, UNSPECIFIED
- WATER
- POVIDONE
- TITANIUM DIOXIDE
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- GLYCERIN
- GELATIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69729-056 | 69729-056-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SORBITOL | 506T60A25R | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| WATER | 059QF0KO0R | IACT |
| POVIDONE | FZ989GH94E | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| GELATIN | 2G86QN327L | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2026-01-30 | full-release | 2026-06-01 01:49:07 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 4c4b37a6-d3e2-f7e3-e063-6294a90a7f8c | 4c4b2f47-fa6f-37c9-e063-6394a90a1519 | 2026-01-30 | Warnings | 4c4b2f47-fa6f-37c9-e063-6394a90a1519 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.