{ "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": "2026-06-02", "results": { "skip": 0, "limit": 1, "total": 12 } }, "results": [ { "spl_product_data_elements": [ "RESFRIOL D Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl CROSPOVIDONE, UNSPECIFIED TALC SILICON DIOXIDE MAGNESIUM STEARATE POVIDONE, UNSPECIFIED PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACETAMINOPHEN ACETAMINOPHEN CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE MICROCRYSTALLINE CELLULOSE A15" ], "active_ingredient": [ "ACTIVE INGREDIENTS (in each tablet) Acetaminophen 500 mg Chlorpheniramine Maleate 4 mg Phenylephrine HCl 10 mg" ], "purpose": [ "PURPOSE Pain Reliever/Fever Reducer Antihistamine Nasal decongestant" ], "indications_and_usage": [ "Uses: temporarily relieves these symptoms of hay fever or other respiratory allergies: headache sinus congestion & pressure nasal congestion runny nose and sneezing minor aches & pain temporarily relieves these additional symptoms of hay fever: nose or throat itching itchy, watery eyes helps clear nasal passages helps decongest sinus opening and passages" ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take : more than 6 tablets in 24 hours, which is the maximum daily amount for this product with other drugs contains acetaminophen 3 or more alcoholic drinks every day while using this product. Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult 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. if you have ever had an allergic reaction to this product or any of its ingredients to make a child sleepy Ask a doctor before use if you have: liver disease heart disease high blood pressure thyroid disease glaucoma diabetes trouble urinating due to enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are: taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product: do not use more than directed excitability may occur, especially in children drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if: nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or last more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition. If pregnant or breast-feeding: ask a health professional before use. Keep out of reach of children. 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. Prompt medical attention is critical for adults as well as for children even if you do not 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. if you have ever had an allergic reaction to this product or any of its ingredients to make a child sleepy" ], "ask_doctor": [ "Ask a doctor before use if you have: liver disease heart disease high blood pressure thyroid disease glaucoma diabetes trouble urinating due to enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are: taking the blood thinning drug warfarin taking sedatives or tranquilizers" ], "when_using": [ "When using this product: do not use more than directed excitability may occur, especially in children drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery" ], "stop_use": [ "Stop use and ask a doctor if: nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or last more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition." ], "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. 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. 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 directed - see overdose warning Swallow whole; do not crush, chew or dissolve Do not exceed 6 tablets per 24 hours Adults and children 12 years of age & over 1 tablet with water every 4-6 hours as needed Children 4 to 12 years of age Ask a doctor Children under 4 years of age Do not use" ], "dosage_and_administration_table": [ "
Adults and children 12 years of age & over1 tablet with water every 4-6 hours as needed
Children 4 to 12 years of ageAsk a doctor
Children under 4 years of ageDo not use
" ], "storage_and_handling": [ "Other information: Store at room temperature between 20-25°C (68-77ºF); excrusions permitted between 15°C - 30°C (59°F - 86°F) Avoid excessive heat and humidity Tamper Evident: do not use if package or blister unit is open or shows any sing of tampering." ], "inactive_ingredient": [ "Inactive ingredients: Microcrystalline cellulose, Polyvinylpyrrolidone,Crospovidone, Magnesium stearate, Colloidal silicon dioxide, Purified talc" ], "questions": [ "Questions or comments? Call: (619) 600-5632 (Mon-Fri 9am-5pm EST) or https://www.opmx.us" ], "spl_unclassified_section": [ "Exclusively distributed by: OPMX San Diego, CA 92154 Phone: 619-600-5632" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 144 TABLETS NDC 69729-323-38 RESFRIOL D Actaminophen 500 mg - Pain reliever/Fever Reducer Chlorpheniramine Maleate 4 mg - Antihistamine Phenylephrine HCl 10 mg - Nasal decongestant Cold/Allergy Relief To relieve common symptoms of Cold & Allergy such as: Headache Sneezing Nasal Congestion Itchy, Watery Eyes and Runny Nose ​ ​144 Tablets (72 Pouches of 2 tablets) RD144", "PRINCIPAL DISPLAY PANEL - 12 TABLETS NDC 69729-323-37 RESFRIOL D Actaminophen 500 mg - Pain reliever/Fever Reducer Chlorpheniramine Maleate 4 mg - Antihistamine Phenylephrine HCl 10 mg - Nasal decongestant Cold/Allergy Relief To relieve common symptoms of Cold & Allergy such as: Headache Sneezing Nasal Congestion Itchy, Watery Eyes and Runny Nose ​ ​12 Tablets (6 Pouches of 2 tablets) RD12", "PRINCIPAL DISPLAY PANEL - 2 Tablets NDC 69729-323-27 RESFRIOL D Actaminophen 500 mg - Pain reliever/Fever Reducer Chlorpheniramine Maleate 4 mg - Antihistamine Phenylephrine HCl 10 mg - Nasal decongestant Cold/Allergy Relief To relieve common symptoms of Cold & Allergy such as: Headache Sneezing Nasal Congestion Itchy, Watery Eyes and Runny Nose ​ ​2 Tablets RD2" ], "set_id": "0e9c96b9-41ac-0faf-e063-6294a90a8ab5", "id": "0fe17f30-ec4a-8f4e-e063-6294a90a1801", "effective_time": "20240126", "version": "3", "openfda": { "application_number": [ "M012" ], "brand_name": [ "RESFRIOL D" ], "generic_name": [ "ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL" ], "manufacturer_name": [ "OPMX LLC" ], "product_ndc": [ "69729-323" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "CHLORPHENIRAMINE MALEATE", "PHENYLEPHRINE HYDROCHLORIDE" ], "rxcui": [ "2463332" ], "spl_id": [ "0fe17f30-ec4a-8f4e-e063-6294a90a1801" ], "spl_set_id": [ "0e9c96b9-41ac-0faf-e063-6294a90a8ab5" ], "package_ndc": [ "69729-323-38", "69729-323-37", "69729-323-27" ], "is_original_packager": [ true ], "upc": [ "0856828008236", "0856828008137", "0856828008229" ], "unii": [ "362O9ITL9D", "V1Q0O9OJ9Z", "04JA59TNSJ" ] } } ] }