Agrifen

Agrifen
SPL v1
SPL
SPL Set ID 31aaa8e7-7980-1e00-e063-6294a90a18d0
Route
ORAL
Published
Effective Date 2025-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Phenylephrine (5 mg) Dextromethorphan (10 mg)
Inactive Ingredients
Fd&c Red No. 40 Propylene Glycol Glycerin Water Povidone Sorbitol Fd&c Yellow No. 6 Polyethylene Glycol, Unspecified Gelatin Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Shape: oval Color: red Size: 20 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-31
Description

Active ingredients (in each Softgel) Purposes Acetaminophen 325 mg Pain reliever/Fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCl 5mg Nasal descongestant

Medication Information

Description

Active ingredients (in each Softgel) Purposes Acetaminophen 325 mg Pain reliever/Fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCl 5mg Nasal descongestant

Uses

Temporarily relieves common cold/flu symptoms:

  • Nasal congestion
  • Cough due to minor throat & bronchial irritation
  • Sore throat
  • Headache
  • Minor aches and pains
  • Fever
Section 51945-4

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

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

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

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.
Questions?

Call toll free 619-600-5632

Monday through Friday 9AM - 5PM EST

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

Other Information
  • Store at room temperature.
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.

Inactive Ingredients

FD&C Red No.40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, titanium dioxide.

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.

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.

Structured Label Content

Uses

Temporarily relieves common cold/flu symptoms:

  • Nasal congestion
  • Cough due to minor throat & bronchial irritation
  • Sore throat
  • Headache
  • Minor aches and pains
  • Fever
Section 51945-4 (51945-4)

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

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

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

Do Not Use (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.
Questions?

Call toll free 619-600-5632

Monday through Friday 9AM - 5PM EST

Active Ingredient (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

Other Information (Other information)
  • Store at room temperature.
Overdose Warning: (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.

Inactive Ingredients (Inactive ingredients)

FD&C Red No.40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, titanium dioxide.

When Using This Product, (When using this product,)

do not use more than directed.

Stop Use and Ask A Doctor If (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 (If pregnant or breast-feeding)

ask a health professional before use.

Ask A Doctor Before Use If You Have (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: (Ask a doctor or pharmacist before use if you are:)

Taking the blood thinning drug warfarin.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:50.445646 · Updated: 2026-03-14T23:08:10.789867