FDA.reportPublic FDA data

AGRIFEN

Manufacturer
OPMX LLC
Effective date
2026-09-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-10-06 02:03:29

Label at a glance#

ProductAGRIFEN
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure7 sections

Dosage and administration

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

Storage and handling

Store at room temperature.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each Softgel)Purposes
Acetaminophen 325 mgPain reliever/Fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Phenylephrine HCl 5mgNasal descongestant

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves common cold/flu symptoms:

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

Uses

OTC - PURPOSE SECTION

  • Pain reliever/Fever reducer
  • Cough suppressant
  • Nasal descongestant

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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:

OTC - ASK DOCTOR/PHARMACIST SECTION

Taking the blood thinning drug warfarin.

When using this product,

OTC - WHEN USING SECTION

do not use more than directed.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Overdose warning:

OVERDOSAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • Take only as directed.
  • Do not exceed 4 doses per 24 hours.
Adults & children 12 yrs & over2 softgels with water every 4 hrs
Children 4 to under 12 yrsAsk a doctor
Children under 4 yrsDo not use

Other information

STORAGE AND HANDLING SECTION

  • Store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

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

agrifenagrifen

22

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130810053181645GTIN-13: 0810053181645
EAN-13: 0810053181645
GTIN-12: 810053181645
UPC-A: 810053181645
GTIN storage (14 digits): 00810053181645		-Agrifen w10 Softgel (ES-EN) Rev. 03.2025_001 (1).jpg
QR code linkQR Codeopmx.us/-Agrifen w10 Softgel (ES-EN) Rev. 03.2025_001 (1).jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69729-80269729-802-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
FD&C RED NO. 40WZB9127XOAIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POVIDONEFZ989GH94EIACT
SORBITOL506T60A25RIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
GELATIN2G86QN327LIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-03-31full-release2026-06-01 00:58:24

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AGRIFENACETAMINOPHEN, DEXTOMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEOPMX LLC31aaa8e7-7980-1e00-e063-6294a90a18d02025-03-31WarningsExact identifier
ndc (package): 69729-802-10
ndc (product): 69729-802
ndc11 (package): 69729080210
spl set id: 31aaa8e7-7980-1e00-e063-6294a90a18d0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.