{"active_ingredient":["ACTIVE INGREDIENTS (in each tablet) Acetaminophen 500 mg Chlorpheniramine Maleate 4 mg Phenylephrine HCl 10 mg"],"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"],"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"],"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":["<table border=\"0\" width=\"100%\"><tbody><tr><td>Adults and children 12 years of age &amp; over</td><td>1 tablet with water every 4-6 hours as needed</td></tr><tr><td>Children 4 to 12 years of age</td><td>Ask a doctor</td></tr><tr><td>Children under 4 years of age</td><td>Do not use</td></tr></tbody></table>"],"effective_time":"20260724","id":"575f6505-ff6d-5079-e063-6394a90accc2","inactive_ingredient":["Inactive ingredients: Microcrystalline cellulose, Polyvinylpyrrolidone, Crospovidone, Magnesium stearate, Colloidal silicon dioxide, Purified talc. Inactive ingredients : magnesium stearate, povidone, silicon dioxide, sodium benzoate, sodium starch glycolate, starch, talc."],"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: itching of the nose or throat itchy, watery eyes helps clear nasal passages helps decongest sinus opening and passages"],"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."],"openfda":{"application_number":["M012"],"brand_name":["COLDTAC ULTRA"],"generic_name":["ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL"],"is_original_packager":[true],"manufacturer_name":["OPMX LLC"],"package_ndc":["69729-133-38","69729-133-37","69729-133-06","69729-133-27","69729-133-50"],"product_ndc":["69729-133"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["2463332"],"spl_id":["575f6505-ff6d-5079-e063-6394a90accc2"],"spl_set_id":["0e9d506d-8c0c-ab6b-e063-6294a90a5ab6"],"substance_name":["PHENYLEPHRINE HYDROCHLORIDE","ACETAMINOPHEN","CHLORPHENIRAMINE MALEATE"],"unii":["04JA59TNSJ","362O9ITL9D","V1Q0O9OJ9Z"],"upc":["0856828008427","0810053181256","0856828008151","0856828008410"]},"other_safety_information":["Other information: Store at room temperature between 25°C (77°F); excursions 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 sign of tampering"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 144 TABLETS NDC 69729-133-38 COLDTAC ULTRA Actaminophen 500 mg, Chlorpheniramine Maleate 4 mg, Phenylephrine HCl 10 mg Effective and Quick Relief from Cold & Flu Symptoms Headache Fever Body Aches Sneezing Runny Nose Watery Eye Nasal Congestion Sore Throat​ ​144 Tablets (72 Packs of 2 tablets) Cold144","PRINCIPAL DISPLAY PANEL - 12 TABLETS NDC 69729-133-37 COLDTAC ULTRA Actaminophen 500 mg, Chlorpheniramine Maleate 4 mg, Phenylephrine HCl 10 mg Effective and Quick Relief from Cold & Flu Symptoms Headache Fever Body Aches Sneezing Runny Nose Watery Eye Nasal Congestion Sore Throat​ ​12 Tablets (6 Packs of 2 tablets) BOX 37 ESP","PRINCIPAL DISPLAY PANEL - 6 TABLETS NDC 69729-133-06 COLDTAC ULTRA Actaminophen 500 mg, Chlorpheniramine Maleate 4 mg, Phenylephrine HCl 10 mg Effective and Quick Relief from Cold & Flu Symptoms Headache Fever Body Aches Sneezing Runny Nose Watery Eye Nasal Congestion Sore Throat​ ​6 Tablets (3 Packs of 2 tablets) BOX2-3 ESP","PRINCIPAL DISPLAY PANEL - 2 TABLETS NDC 69729-133-27 COLDTAC ULTRA Actaminophen 500 mg, Chlorpheniramine Maleate 4 mg, Phenylephrine HCl 10 mg Effective and Quick Relief from Cold & Flu Symptoms Headache Fever Body Aches Sneezing Runny Nose Watery Eye Nasal Congestion Sore Throat​ ​2 Tablets Cold2","PRINCIPAL DISPLAY PANEL - 100 TABLETS NDC 69729-133-50 COLDTAC ULTRA Actaminophen 500 mg / Pain reliever Chlorpheniramine Maleate 4 mg / Antihistamine Phenylephrine HCl 10 mg / Nasal decongestant Cold & Flu Relief Medicine Alivia los Sintomas de GRIPE y RESFRIADO 100 Tablets / Tabletas 50 Packs / Sobres 2 Tablets / Tabletas BOX100"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding: ask a health professional before use."],"purpose":["PURPOSE Pain Reliever/Fever Reducer Antihistamine Nasal decongestant"],"questions":["Questions or comments? Call: (619) 600-5632 (Mon-Fri 9am-5pm EST) or https://www.opmx.us"],"set_id":"0e9d506d-8c0c-ab6b-e063-6294a90a5ab6","spl_product_data_elements":["COLDTAC ULTRA Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACETAMINOPHEN ACETAMINOPHEN CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE STARCH, CORN SODIUM BENZOATE SODIUM STARCH GLYCOLATE TYPE A TALC SILICON DIOXIDE MAGNESIUM STEARATE POVIDONE, UNSPECIFIED A15"],"spl_unclassified_section":["Exclusively distributed by: OPMX San Diego, CA 92154 Phone: 619-600-5632"],"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."],"version":"5","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."],"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"]}