Active Ingredients (In Each Softgel)
Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg
Viro-flu Am Capsule, Liquid Filled
FDA Label NDC 69729-831
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 (NDC 69729-831). 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 active ingredients (in each softgel), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or 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
Purpose
- Analgesic
- Cough suppressant
- Nasal decongestant
Uses
Temporarily relieves common cold/flu symptoms:
- nasal congestion
- 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 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
- skin reddening
- blisters
- rash
- if a skin reaction occurs, stop use and seek medical help right away
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may
include:
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
- 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 Doctor Or 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.
- 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
Keep out of reach of children
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 symptoms.
Directions
- 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 |
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?
Questions? Call toll free 619-600-5632 Monday through Friday 9AM - 5PM EST.
Distributed By
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
* Please review the disclaimer below.
