FDA Label for Agrifen

Active Ingredient

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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

• Skin reddening
• Blisters
• Rash
• If a skin reactions occurs, stop use and seek medical help right away

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