{"active_ingredient":["Active ingredients (in each Day caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant","Active ingredients (in each Night caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Chlorpheniramine Maleate 2 mg Antihistamine Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant"],"active_ingredient_table":["
Active ingredients (in each Day caplet)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant
","
Active ingredients (in each Night caplet)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Chlorpheniramine Maleate 2 mgAntihistamine
Dextromethorphan HBr 10 mgCough suppressant
Phenylephrine HCl 5 mgNasal decongestant
"],"ask_doctor":["Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus)","Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis glaucoma"],"ask_doctor_or_pharmacist":["Ask a doctor of pharmacist before use if you are taking the blood thinning drug warfarin","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","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"],"dosage_and_administration":["Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 4 hours swallow whole – do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours children under 12 years ask a doctor","Directions do not use more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 4 hours swallow whole – do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours children under 12 years ask a doctor"],"dosage_and_administration_table":["
adults and children 12 years and overtake 2 caplets every 4 hoursswallow whole – do not crush, chew, or dissolvedo not take more than 10 caplets in 24 hours
children under 12 yearsask a doctor
","
adults and children 12 years and overtake 2 caplets every 4 hoursswallow whole – do not crush, chew, or dissolvedo not take more than 10 caplets in 24 hours
children under 12 yearsask a doctor
"],"effective_time":"20240718","id":"1d8bb148-461a-3efa-e063-6394a90ad4fc","inactive_ingredient":["Inactive ingredients acesulfame potassium, colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #2 aluminum lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide","Inactive ingredients acesulfame potassium, colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide"],"indications_and_usage":["Uses for the temporary relief of the following cold/flu symptoms: minor aches and pain headache sore throat nasal congestion cough helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever","Uses for the temporary relief of the following cold/flu symptoms: minor aches and pains headache sore throat nasal congestion cough sinus congestion and pressure sneezing and runny nose helps clear nasal passages relieves cough to help you sleep temporarily reduces fever"],"keep_out_of_reach_of_children":["Keep out of reach of children.","Keep out of reach of children."],"openfda":{"application_number":["M012"],"brand_name":["Cold and Flu Severe Day and Night"],"generic_name":["ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["CHAIN DRUG MARKETING ASSOCIATION, INC"],"package_ndc":["83324-092-24"],"product_ndc":["83324-092"],"product_type":["HUMAN OTC DRUG"],"rxcui":["1086991","1110988","2634819"],"spl_id":["1d8bb148-461a-3efa-e063-6394a90ad4fc"],"spl_set_id":["9b74dd00-8f84-4fce-b5ea-df886b595326"]},"overdosage":["Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL QUALITY CHOICE® NDC 83324-092-24 †Compare to Active Ingredients in TYLENOL® Cold + Flu Severe Day and Night Cold + Flu Severe Day + Night For Adults DAY Actaminophen, Dextromethorphan HBr, Phenylephrine HCl, Guaifenesin Pain Reliever | Fever Reducer, Cough Suppressant, Nasal Decongestant, Expectorant For Relief of: Head + Body Aches Fever + Sore Throat Cough Nasal Congestion Mucus + Chest Congestion 16 DAY CAPLETS NIGHT Actaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl Pain Reliever | Fever Reducer, Antihistamine, Cough Suppressant, Nasal Decongestant, For Relief of: Head+ Body Aches Fever + Sore Throat Cough Nasal Congestion Runny Nose 8 NIGHT CAPLETS Actual Size 24 COOL TASTE CAPLETS image description"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use.","If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Active ingredients (in each Day caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant","Active ingredients (in each Night caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Chlorpheniramine Maleate 2 mg Antihistamine Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant"],"purpose_table":["
Active ingredients (in each Day caplet)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant
","
Active ingredients (in each Night caplet)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Chlorpheniramine Maleate 2 mgAntihistamine
Dextromethorphan HBr 10 mgCough suppressant
Phenylephrine HCl 5 mgNasal decongestant
"],"set_id":"9b74dd00-8f84-4fce-b5ea-df886b595326","spl_product_data_elements":["Cold and Flu Severe Day and Night Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride Cold plus Flu Severe ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE ACESULFAME POTASSIUM SILICON DIOXIDE CROSCARMELLOSE SODIUM CROSPOVIDONE, UNSPECIFIED D&C YELLOW NO. 10 ALUMINUM OXIDE FD&C BLUE NO. 2 MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE, UNSPECIFIED STARCH, PREGELATINIZED CORN PROPYLENE GLYCOL STEARIC ACID TALC TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE AAA;1136 Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride ACESULFAME POTASSIUM SILICON DIOXIDE CROSCARMELLOSE SODIUM FD&C BLUE NO. 1 ALUMINUM OXIDE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE, UNSPECIFIED STARCH, PREGELATINIZED CORN PROPYLENE GLYCOL STEARIC ACID TALC TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE AAA;1139"],"spl_unclassified_section":["Cold + Flu Severe Day Drug Facts","Cold + Flu Severe Night Drug Facts"],"stop_use":["Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough 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 cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition.","Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough 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 cough comes back or occurs with rash or headache that lasts These could be signs of a serious condition."],"storage_and_handling":["Other information store between 20-25°C (68-77°F) in a dry place retain carton for complete product information and warnings","Other information store between 20-25°C (68-77°F) in a dry place retain carton for complete product information and warnings"],"version":"2","warnings":["Warnings Liver warning This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing 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 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. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor of pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dosage Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough 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 cough comes back or occurs with rash or headache that lasts 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 In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.","Warnings Liver warning This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing 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 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. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis glaucoma 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 exceed recommended dosage excitability may occur, especially in children marked 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, nasal congestion, or cough 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 cough comes back or occurs with rash or headache that lasts 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 In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick 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 exceed recommended dosage","When using this product do not exceed recommended dosage excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery"]}