{"active_ingredient":["Active ingredients (in each Softgels) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 15 mg Cough suppressant Doxylamine succinate 6.25 mg Antihistamine"],"active_ingredient_table":["
Active ingredients (in each Softgels)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 15 mgCough suppressant
Doxylamine succinate 6.25 mgAntihistamine
"],"ask_doctor":["Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland"],"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."],"dosage_and_administration":["Directions Take only as directed Do not exceed 4 doses per 24 hrs Adults & children 12 yrs & over 2 softgels with water every 6 hrs Children 4 to under 12 yrs Ask a doctor Children under 4 yrs Do not use"],"dosage_and_administration_table":["
Adults & children 12 yrs & over2 softgels with water every 6 hrs
Children 4 to under 12 yrsAsk a doctor
Children under 4 yrsDo not use
"],"effective_time":"20250717","id":"3a22cbea-540f-4e02-e063-6294a90aef45","inactive_ingredient":["Inactive ingredients D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, titanium dioxide"],"indications_and_usage":["Uses Temporarily relieves common cold/flu symptoms: Cough due to minor throat & bronchial irritation Sore throat Headache Minor aches & pains Fever Runny nose & sneezing"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"application_number":["M012"],"brand_name":["Pentrexcilina Night Time"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE"],"is_original_packager":[true],"manufacturer_name":["OPMX LLC"],"package_ndc":["69729-041-10"],"product_ndc":["69729-041"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1094549"],"spl_id":["3a22cbea-540f-4e02-e063-6294a90aef45"],"spl_set_id":["e11e5c17-28f2-7186-e053-2995a90a51f6"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","DOXYLAMINE SUCCINATE","ACETAMINOPHEN"],"unii":["9D2RTI9KYH","V9BI9B5YI2","362O9ITL9D"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 69729-041-10 Pentrexcilina Night-Time EXTRA STRENGH Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate COLD, FLU & COUGH TOS, GRIPE Y RESFRIADO 10 Softgels Pentrexcilina_Night Time"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Active ingredients (in each Softgels) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 15 mg Cough suppressant Doxylamine succinate 6.25 mg Antihistamine"],"purpose_table":["
Active ingredients (in each Softgels)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 15 mgCough suppressant
Doxylamine succinate 6.25 mgAntihistamine
"],"questions":["Questions? Call toll free 619-600-5632 Monday through Friday 9AM - 5PM EST"],"set_id":"e11e5c17-28f2-7186-e053-2995a90a51f6","spl_product_data_elements":["Pentrexcilina Night Time Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate D&C YELLOW NO. 10 FD&C BLUE NO. 1 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL WATER SORBITOL DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE ACETAMINOPHEN ACETAMINOPHEN AP02"],"spl_unclassified_section":["Drug Facts","Made for: RRX Exclusively distributed by: OPMX Chula Vista, CA 91910"],"stop_use":["Stop use and ask a doctor if Pain 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 at room temperature"],"version":"3","warnings":["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"],"warnings_and_cautions":["Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hrs, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily 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, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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. Ask a doctor before use if you have liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland When using this product Excitability may occur, especially in children Marked drowsiness may occur Avoid Alcoholic drinks Be careful when driving a motor vehicle or operating machinery Alcohol, sedatives, & tranquilizers may increase drowsiness Stop use and ask a doctor if Pain 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. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms."],"when_using":["When using this product Excitability may occur, especially in children Marked drowsiness may occur Avoid Alcoholic drinks Be careful when driving a motor vehicle or operating machinery Alcohol, sedatives, & tranquilizers may increase drowsiness"]}