Active Ingredient
| Active ingredients (in each Softgel) | Purposes |
| Acetaminophen 325 mg | Pain reliever/Fever reducer |
| Dextromethorphan HBr 10 mg | Cough suppressant |
| Phenylephrine HCl 5mg | Nasal descongestant |
Agrifen Capsule, Liquid Filled
FDA Label NDC 69729-802
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 Agrifen (NDC 69729-802). 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 ingredient, 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,, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
Temporarily relieves common cold/flu symptoms:
- Nasal congestion
- Cough due to minor throat & bronchial irritation
- Sore throat
- Headache
- Minor aches and pains
- Fever
- Pain reliever/Fever reducer
- Cough suppressant
- Nasal descongestant
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 reactions 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 accompained 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
- Hear disease
- Diabetes
- High blood pressure
- Trouble urinating due to enlarged prostate gland
- Cough that occurs with too mcuh plegm (mucus)
- Persistent or chronic cough 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
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 dot notice any signs or symptoms.
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 to 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
Package Label.Principal Display Panel
NDC 69729-802-10
AGRIFEN
Acetaminophen 325 mg
Dextomethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Dolor de Cabeza
Headache
Congestión Nasal
Nassal Congestion
Ojos llorosos
Itchi, Watery eyes
Escurrimiento Nasal y Estornudos
Runny Nose & Sneezing
10 Soft Gels
Exclusively distributes by:
OPMX
Chula Vista, CA 91910
Phine: 619-600-5632
TAMPER EVIDENT:
Do not use if package is opened or if blister unit is torn, broken or shows any sign of tampering
* Please review the disclaimer below.
