{"active_ingredient":["Active ingredients (in each caplet) Acetaminophen 500 mg Diphenhydramine HCl 25 mg"],"ask_doctor":["Ask a doctor before use if you have liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland"],"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. with any other product containing diphenhydramine, even one used on the skin in children under 12 years of age 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 at bedtime if needed do not take more than 2 caplets in 24 hours, unless directed by a doctor children under 12 years ask a doctor"],"dosage_and_administration_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td>adults and children 12 years and over</td><td><list listType=\"unordered\"><item>take 2 caplets at bedtime if needed</item><item>do not take more than 2 caplets in 24 hours, unless directed by a doctor</item></list></td></tr><tr><td>children under 12 years</td><td>ask a doctor</td></tr></tbody></table>"],"effective_time":"20250220","id":"2e9472c4-b466-e4fd-e063-6394a90ad2f6","inactive_ingredient":["Inactive ingredients acacia gum‡, agave fiber‡, agave syrup‡, calcium carbonate‡, organic carnauba wax, cellulose‡, dextrose‡, dibehenin (vegetable source)‡, glycerin‡, guar gum‡, maltodextrin‡, organic palm olein, rice extract‡, rice hulls‡, sodium bicarbonate‡, organic sunflower lecithin, sunflower oil‡ ‡natural"],"indications_and_usage":["Uses temporarily relieves occasional headaches and minor aches and pains with accompanying sleeplessness"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"application_number":["M013"],"brand_name":["Genexa Acetaminophen PM Extra Strength"],"generic_name":["ACETAMINOPHEN"],"is_original_packager":[true],"manufacturer_name":["Genexa Inc."],"package_ndc":["69676-0063-2","69676-0063-5"],"product_ndc":["69676-0063"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1092189"],"spl_id":["2e9472c4-b466-e4fd-e063-6394a90ad2f6"],"spl_set_id":["d82cf6f3-a291-ca2b-e053-2a95a90a6de1"],"substance_name":["ACETAMINOPHEN","DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["362O9ITL9D","TC2D6JAD40"],"upc":["0850015736148"]},"other_safety_information":["Other information each caplet contains: calcium 12 mg store between 20-25°C (68-77°F)"],"overdosage":["Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt 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":["Genexa® MEDICINE MADE CLEAN For Adults Acetaminophen PM Extra Strength with Diphenhydramine HCl Pain Reliever Nighttime Sleep Aid Compare to a ctive ingredients in Tylenol® PM Extra Strength Caplets* 100 Caplets Non-habit forming How we're different Made without: crospovidone, polyethylene glycol, titanium dioxide & more! Adult APAP PM_Carton_R-20220323"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Pain reliever Nighttime sleep aid"],"questions":["Questions? 1-855-436-3921"],"recent_major_changes":["Directions • do not take more than directed (see Overdose warning) adults and children 12 years and over take 2 caplets at bedtime if needed do not take more than 2 caplets in 24 hours, unless directed by a doctor children under 12 years ask a doctor"],"recent_major_changes_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td>adults and children 12 years and over</td><td><list listType=\"unordered\"><item>take 2 caplets at bedtime if needed</item><item>do not take more than 2 caplets in 24 hours, unless directed by a doctor</item></list></td></tr><tr><td>children under 12 years</td><td> ask a doctor</td></tr></tbody></table>"],"set_id":"d82cf6f3-a291-ca2b-e053-2a95a90a6de1","spl_product_data_elements":["Genexa Acetaminophen PM Extra Strength Acetaminophen CALCIUM CARBONATE RICE BRAN ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE POWDERED CELLULOSE INULIN PALM OIL ACACIA AGAVE TEQUILANA JUICE CARNAUBA WAX DEXTROSE GUAR GUM MALTODEXTRIN SODIUM BICARBONATE LECITHIN, SUNFLOWER GLYCERYL DIBEHENATE SUNFLOWER OIL GLYCERIN Oblong G7 LIGHT BEIGE WITH SPECKLES"],"spl_unclassified_section":["Drug Facts","Carton and bottle are safety sealed. DO NOT use if seal on top and/or bottom of carton or under cap of bottle is disturbed or missing. *This product is not manufactured or distributed by Johnson & Johnson Corp., owner of the registered trademark Tylenol® PM Extra Strength Caplets. Patent Pending | Distributed by: Genexa Inc. Atlanta, GA 30318 | genexa.com Made in the USA with globally sourced ingredients NDC 69676-0063-2"],"stop_use":["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."],"version":"5","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 the 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 glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland Ask a doctor or 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 (1-800-222-1222). 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 drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery"]}