{"active_ingredient":["Active ingredients (in each caplet) Acetaminophen 500 mg Diphenhydramine HCl 25 mg"],"dosage_and_administration":["Directions • do not take more than directed (see overdose warning) • do not take more than 2 caplets in 24 hours adults & children 12 years of age and over • take 2 caplets at bedtime • do not take more than 2 caplets of this product in 24 hours children under 12 years of age do not use"],"dosage_and_administration_table":["
adults & children 12 years of age and over • take 2 caplets at bedtime • do not take more than 2 caplets of this product in 24 hours
children under 12 years of age do not use
"],"effective_time":"20231113","id":"f813df18-8e46-48b8-925e-dc4f8da0eb14","inactive_ingredient":["Inactive ingredients croscarmellose sodium, FD&C blue#1 aluminium lake, FD&C blue#2 aluminium lake, hypromelloses, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone K30, purified water, silicon dioxide, sodium starch glycolate, starch, talc, titanium dioxide"],"indications_and_usage":["Uses Temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness"],"keep_out_of_reach_of_children":["Keep out of reach of children. Overdose warning: 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 children even if you do not notice any signs or symptoms."],"openfda":{"application_number":["M013"],"brand_name":["RIGHT REMEDIES EXTRA STRENGTH PM Pain Relief"],"generic_name":["ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Strive Pharmaceuticals Inc."],"package_ndc":["70692-149-03","70692-149-31","70692-149-05"],"product_ndc":["70692-149"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1092189"],"spl_id":["f813df18-8e46-48b8-925e-dc4f8da0eb14"],"spl_set_id":["8badbaad-eb35-4251-a779-00474819360d"],"substance_name":["ACETAMINOPHEN","DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["362O9ITL9D","TC2D6JAD40"]},"package_label_principal_display_panel":["Packaging Pain Relief PM-149 Pain Relief PM-149"],"purpose":["Purposes Pain reliever Nighttime sleep aid"],"questions":["Questions or comments? 1-888-577-8033 Monday-Friday 8am-4pm EST"],"set_id":"8badbaad-eb35-4251-a779-00474819360d","spl_product_data_elements":["RIGHT REMEDIES EXTRA STRENGTH PM Pain Relief Acetaminophen, Diphenhydramine hydrochloride ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CROSCARMELLOSE SODIUM FD&C BLUE NO. 1 ALUMINUM LAKE FD&C BLUE NO. 2 HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE K30 WATER SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A STARCH, CORN TALC TITANIUM DIOXIDE S149"],"spl_unclassified_section":["Drug Facts","compare to active ingredients of Extra Strength TYLENOL ® PM* TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING FROM BOTTLE READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION *This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division., owner of the registered trademark Tylenol ® PM. Distributed by: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816 Product of India Packaged & Quality Assured in USA CT7069214903 REV.00-082021"],"storage_and_handling":["Other information • each caplet contains: sodium 3 mg (very low sodium) • store at room temperature between 20-25ºC (68-77ºF). • avoid excessive heat, cold and humidity."],"version":"1","warnings":["Warnings Liver warning: This product contains acetaminophen. 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. 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 • with any other product containing diphenhydramine, even one used on skin • in children under 12 years of age • 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 • a breathing problem such as emphysema or chronic bronchitis • trouble urinating due to an enlarged prostate gland • glaucoma Ask a doctor or a pharmacist before use if you are • taking the blood thinning drug warfarin • taking sedatives or tranquilizers When using this product • drowsiness will occur • avoid alcoholic drinks • do not drive a motor vehicle or operate machinery Stop use and ask a doctor if • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness • pain gets worse or lasts more than 10 days • fever gets worse or lasts 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: 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 children even if you do not notice any signs or symptoms."]}