{"active_ingredient":["Active ingredient Acetaminophen 325 mg Chlorpheniramine maleate 2 mg* Phenylephrine HCl 5 mg * antihistamine in nighttime dose only"],"ask_doctor":["Ask a doctor before use if you have • liver disease • heart disease • glaucoma • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostrate 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 • sedatives or tranquilizers • the blood thinning drug warfarin"],"do_not_use":["Do not use • in a child under 4 years of age • if you are allergic to acetaminophen • 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."],"dosage_and_administration":["Directions • do not use more than directed • daytime - orange caplets - take every 4 hours, while symptoms persist • do not take more than 8 daytime caplets in 24 hours, unless directed by a doctor • nighttime - green caplets - take no sooner than 4 hours after the last daytime dose • wait at least 4 hours before taking an additional nighttime dose, if needed • do not take more than 4 nighttime caplets in 24 hours, unless directed by a doctor Age Dose children under 4 years of age do not use children 4 to under 12 years of age do not use unless directed by a doctor adults and children 12 years of age and over 2 caplets"],"dosage_and_administration_table":["
Age Dose
children under 4 years of age do not use
children 4 to under 12 years of age do not use unless directed by a doctor
adults and children 12 years of age and over 2 caplets
"],"effective_time":"20190725","id":"4f2db7f1-6ae8-41c1-866c-603fb10a285a","inactive_ingredient":["Inactive ingredients • daytime caplet - benzoic acid, carnauba wax, D&C yellow #10 lake, FD&C red #40 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide. • nighttime caplet - benzoic acid, carnauba wax, D&C yellow #10 lake, FD&C blue #1 lake, FD&C red #40 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, stearic acid, titanium dioxide."],"indications_and_usage":["Uses • daytime (orange caplets) - temporarily relieves: • minor aches and pains • headaches • nasal congestion • sinus congestion & pressure • nighttime (green caplets) - provides the same relief as the daytime caplets plus temporarily relieves: • runny nose • sneezing"],"keep_out_of_reach_of_children":["Keep out of reach of children 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":{},"package_label_principal_display_panel":["Package/Label Principal Display Panel Comtrex 2083.JPG"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding ask a health care professional before use."],"purpose":["Purpose Pain reliever / fever reducer Antihistamine* Nasal decongestant"],"set_id":"801d3659-d0e8-4c3b-ac03-4fc0b9b211dc","spl_product_data_elements":["COMTREX Maximum Strength Day / Night Severe Cold and Sinus Acetaminophen, Chlorpheniramine Maleate, Phenylephrin HCl COMTREX Maximum Strength Daytime Severe Cold and Sinus Acetaminophen, Phenylephrin HCl ACETAMINOPHEN ACETAMINOPHEN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE BENZOIC ACID CARNAUBA WAX D&C YELLOW NO. 10 FD&C RED NO. 40 HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 STARCH, CORN STEARIC ACID TITANIUM DIOXIDE Orange Capsule shaped tablet CxC COMTREX Maximum Strength Nighttime Severe Cold and Sinus Acetaminophen, Chlorpheniramine Maleate, Phenylephrin HCl ACETAMINOPHEN ACETAMINOPHEN CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE BENZOIC ACID CARNAUBA WAX D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 40 HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED STARCH, CORN STEARIC ACID TITANIUM DIOXIDE Green capsule shaped tablet CxS"],"spl_unclassified_section":["Other information • store at controlled room temperature 20-25 ° C (68-77 ° F)","Questions or comments? call 1-800-452-0051"],"stop_use":["Stop use and ask a doctor if • new symptoms occur • you get nervous, dizzy, or sleepless • redness or swelling is present • pain or nasal congestion gets worse or lasts more than 7 days • fever gets worse or lasts more than 3 days"],"version":"2","warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 12 caplets (8 daytime & 4 nighttime total) in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product Sore throat warnings: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly."],"when_using":["When using this product • do not exceed recommended dosage • when using nighttime product: • drowsiness may occur • avoid alcoholic drinks • excitability may occur, especially in children • alcohol, sedatives and tranquilizers may increase drowsiness • be carful when driving a motor vehicle or operating machinery"]}