{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "AGRIFEN Acetaminophen, Dextomethorphan Hydrobromide, Phenylephrine Hydrochloride ACETAMINOPHEN ACETAMINOPHEN FD&C RED NO. 40 PROPYLENE GLYCOL PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE GLYCERIN WATER DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN POVIDONE SORBITOL FD&C YELLOW NO. 6 POLYETHYLENE GLYCOL, UNSPECIFIED GELATIN TITANIUM DIOXIDE Oblong" ], "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 Uses Temporarily relieves common cold/flu symptoms: Nasal congestion Cough due to minor throat & bronchial irritation Sore throat Headache Minor aches and pains Fever Uses Pain reliever/Fever reducer Cough suppressant Nasal descongestant" ], "active_ingredient_table": [ "
Active ingredients (in each Softgel) Purposes
Acetaminophen 325 mg Pain reliever/Fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
Phenylephrine HCl 5mg Nasal descongestant
" ], "indications_and_usage": [ "Uses Temporarily relieves common cold/flu symptoms: Nasal congestion Cough due to minor throat & bronchial irritation Sore throat Headache Minor aches and pains Fever" ], "purpose": [ "Uses Pain reliever/Fever reducer Cough suppressant Nasal descongestant" ], "warnings": [ "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 Keep out of reach of children 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." ], "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." ], "ask_doctor": [ "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_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are: Taking the blood thinning drug warfarin." ], "when_using": [ "When using this product, do not use more than directed." ], "stop_use": [ "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" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding ask a health professional before use." ], "overdosage": [ "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." ], "dosage_and_administration": [ "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" ], "dosage_and_administration_table": [ "
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": [ "Other information Store at room temperature." ], "inactive_ingredient": [ "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": [ "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 agrifen 2" ], "set_id": "31aaa8e7-7980-1e00-e063-6294a90a18d0", "id": "31aaa8e7-7981-1e00-e063-6294a90a18d0", "effective_time": "20250331", "version": "1", "openfda": { "application_number": [ "M012" ], "brand_name": [ "AGRIFEN" ], "generic_name": [ "ACETAMINOPHEN, DEXTOMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE" ], "manufacturer_name": [ "OPMX LLC" ], "product_ndc": [ "69729-802" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "DEXTROMETHORPHAN HYDROBROMIDE", "PHENYLEPHRINE HYDROCHLORIDE" ], "rxcui": [ "1086997" ], "spl_id": [ "31aaa8e7-7981-1e00-e063-6294a90a18d0" ], "spl_set_id": [ "31aaa8e7-7980-1e00-e063-6294a90a18d0" ], "package_ndc": [ "69729-802-10" ], "is_original_packager": [ true ], "upc": [ "0810053181645" ], "unii": [ "362O9ITL9D", "9D2RTI9KYH", "04JA59TNSJ" ] } } ] }