{"active_ingredient":["Active ingredients (in each gelcap) Purpose Acetaminophen 500 mg Pain reliever Diphenhydramine HCl 25 mg Nighttime sleep-aid"],"active_ingredient_table":["
Active ingredients (in each gelcap)
Purpose
Acetaminophen 500 mg
Pain reliever
Diphenhydramine HCl 25 mg
Nighttime sleep-aid
"],"ask_doctor":["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_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 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 gelcaps at bedtime do not take more than 2 gelcaps of this product in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage"],"dosage_and_administration_table":["
adults and children 12 years and over
take 2 gelcaps at bedtimedo not take more than 2 gelcaps of this product in 24 hours
children under 12 years
do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
"],"effective_time":"20221116","id":"ed981cc2-ffd8-9610-e053-2995a90ad26e","inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C red #28, D&C yellow #10, edible ink, FD&C blue #1, FD&C blue #2 aluminum lake, FD&C red #40, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, titanium dioxide, triacetin"],"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."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL †Compare to the active ingredient in Tylenol® PM Extra Strength Rapid Release Gels Marc’s® Extra Strength Pain Reliever PM Rapid Release Pain Reliever/Nighttime Sleep-Aid Acetaminophen, Diphenhydramine HCl • Contains No Aspirin, Non-Habit Forming • Fast Release 80 Gelcaps image description"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Active ingredients (in each gelcap) Purpose Acetaminophen 500 mg Pain reliever Diphenhydramine HCl 25 mg Nighttime sleep-aid"],"purpose_table":["
Active ingredients (in each gelcap)
Purpose
Acetaminophen 500 mg
Pain reliever
Diphenhydramine HCl 25 mg
Nighttime sleep-aid
"],"set_id":"10f6c8ff-c71d-4281-8ab8-741daff1d646","spl_product_data_elements":["Pain Reliever PM Extra Strength Acetaminophen and Diphenhydramine Hydrochloride D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C BLUE NO. 2 FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN HYDROXYPROPYL CELLULOSE (1600000 WAMW) HYPROMELLOSES CELLULOSE, MICROCRYSTALLINE POVIDONE STARCH, CORN STEARIC ACID TITANIUM DIOXIDE TRIACETIN ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE D&C RED NO. 28 SILICON DIOXIDE CROSCARMELLOSE SODIUM dark blue and light blue ends G3"],"spl_unclassified_section":["Drug Facts"],"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"],"storage_and_handling":["Other information store between 20-25ºC (68-77ºF) retain carton for complete product information"],"version":"2","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 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 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). 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 drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery"]}