Drug Facts
Active ingredients (in each Softgel)
- Acetaminophen 325 mg
- Dextromethorphan HBr 10 mg
Viro-flu Am Relief Capsule, Liquid Filled
FDA Label NDC 69729-056
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Opmx Llc for the product Viro-flu Am Relief (NDC 69729-056). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctorpr pharmacist before use if you are:, when using this product,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
- Skin reddening
- Blisters
- Rash
- If a skin reaction occurs, stop use and seek medical help right away.
Allergy allert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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
Other
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
* Please review the disclaimer below.
