FDA.reportPublic FDA data

Agrifen

Manufacturer
OPMX LLC | Rebase Lifescience Private
Effective date
2026-07-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-07-17 21:45:36

Label at a glance#

ProductAGRIFEN
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE
Label structure10 sections

Indications and uses

Temporarily relieves common cold/flu symptoms: Cough due to minor throat & bronchial irritation Sore throat Headache Minor aches and pains Fever

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

Label contents#

Full prescribing information#

Active ingredients (in each Softgel)

OTC - ACTIVE INGREDIENT SECTION

  • Acetaminophen 325 mg
  • Dextromethorphan HBr 10mg

Purpose

OTC - PURPOSE SECTION

  • Pain reliever/ Fever reducer
  • Cough suppressant

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves common cold/flu symptoms:

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

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
  • Heart 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

Keep out of reach of children.

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

OTHER SAFETY INFORMATION

  • 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

Distributed by

SPL UNCLASSIFIED SECTION

Exclusively distributed by:

OPMX

Chula Vista, CA 91910

Phone: 619-600-5632

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69729-816-10

AGRIFEN

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Cold and Flue Relief:

Alivia los Sintomas del Resfriado y Gripe:

Headache

Dolor de Cabeza

Sore Throat

Dolor de Garganta

Itchy, Watery Eyes

Irritacion, Ojos Llorosos

10 softgels

PDP1PDP1

ESPESP

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 Box Label.jpg
QR code linkQR Codeopmx.us/AGRIFEN Box Label.jpg

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69729-81669729-816-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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

Source Document#

Source XML

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, DEXTROMETHORPHAN HYDROBROMIDEOPMX LLC55fa7b02-6613-1049-e063-6294a90a1def2026-07-06WarningsExact identifier
ndc (package): 69729-816-10
ndc (product): 69729-816
ndc11 (package): 69729081610
spl id: 55fa7b02-6614-1049-e063-6294a90a1def
spl set id: 55fa7b02-6613-1049-e063-6294a90a1def

Reported adverse events (FAERS/openFDA)#

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