{ "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": [ "Defensol D Acetaminophen, Chlorpherinamine maleate, Phenylephrine HCI FD&C BLUE NO. 2 HYPROMELLOSE 2208 (100 MPA.S) MAGNESIUM STEARATE POLYETHYLENE GLYCOL 400 POVIDONE STARCH, PREGELATINIZED CORN SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE" ], "active_ingredient": [ "Active ingredients (in each tablet) Acetaminophen 325 mg Chlorpherinamine maleate 2 mg Phenylephrine HCI 5 mg" ], "purpose": [ "Purpose Pain Reliever/ Fever Reducer Antihistamine Nasal Decongestant" ], "indications_and_usage": [ "Uses Temporarily relieves these symptoms associated with cold or flu: headache nasal congestion sore throat fever minor aches and pains Temporarily relieves minor aches, pains and headache as well as these sympotoms of hay fever or other upper respiratory allergies: runny nose sneezing nasal congestion itching of the nose or throat itchy, watery eyes Temporarily relieves minor aches, pains, headache and nasal congestion as well as sinus congestion and pressure, and reduces swelling of nasal passages" ], "warnings": [ "Warnings Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 tablets in any 24-hour period, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Sore throat warning: if sore throat is severe, persits for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly." ], "do_not_use": [ "Do not use To sedate a child or to make a child sleepy 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 two 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. with any other drug containing acetaminophen (prescription or non prescription) . If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist." ], "ask_doctor": [ "Ask doctor before use if you have liver desease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland glaucoma a breathing problem such as emphysema, asthma, or chronic bronchitis" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking any other oral nasal decongestant or stimulant taking any other pain reliever/ fever reducer taking sedatives or tranquilizers" ], "when_using": [ "When using this product do not use more than directed excitability may occur with children drowsiness may occur avoid alcoholic beverages alcohol, sedatives and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery" ], "stop_use": [ "Stop use and ask a doctor if you get nervous, dizzy or sleepless pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children." ], "overdosage": [ "Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "dosage_and_administration": [ "Directions : do not take more than 8 tablets in a 24 hour period. do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage age dose adults and children 12 years and over 2 tablets every 4 hours children under 12 years do not use" ], "dosage_and_administration_table": [ "
age dose
adults and children 12 years and over 2 tablets every 4 hours
children under 12 years do not use
" ], "inactive_ingredient": [ "Inactive ingredients: FD&C blue #2, hypromellose, magnesium stearate, PEG 400, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide" ], "questions": [ "Questions? Menper Distributors, Inc. 1-800-560-5223; M-F 9 AM - 4 PM Eastern" ], "package_label_principal_display_panel": [ "Defensol D Tabs Label" ], "set_id": "f466c660-69eb-4581-81ff-1499fa421d8b", "id": "3a88bd55-586f-64c5-e063-6394a90a6788", "effective_time": "20250722", "version": "5", "openfda": { "application_number": [ "M012" ], "brand_name": [ "Defensol D" ], "generic_name": [ "ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI" ], "manufacturer_name": [ "Menper Distributors, Inc." ], "product_ndc": [ "53145-005" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "CHLORPHENIRAMINE MALEATE", "PHENYLEPHRINE HYDROCHLORIDE" ], "rxcui": [ "1046781" ], "spl_id": [ "3a88bd55-586f-64c5-e063-6394a90a6788" ], "spl_set_id": [ "f466c660-69eb-4581-81ff-1499fa421d8b" ], "package_ndc": [ "53145-005-02", "53145-005-30" ], "is_original_packager": [ true ], "unii": [ "362O9ITL9D", "V1Q0O9OJ9Z", "04JA59TNSJ" ] } } ] }