{"active_ingredient":["Active ingredients (in each geltab) Acetaminophen 500 mg Diphenhydramine HCl 25 mg"],"ask_doctor":["Ask a doctor before use if you have • liver disease • glaucoma • trouble urinating due to an enlarged prostate gland • a breathing problem such as emphysema or chronic bronchitis"],"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 geltabs at bedtime • do not take more than 2 geltabs of this product in 24 hours children under 12 years do not use"],"dosage_and_administration_table":["take 2 geltabs at bedtime do not take more than 2 geltabs of this product in 24 hours
adults and children 12 years and over
••
children under 12 yearsdo not use
"],"effective_time":"20221103","id":"52c9bca2-4e48-4576-a3ec-ee2b9133bbe1","inactive_ingredient":["Inactive ingredients crospovidone, D&C red #33 aluminum lake, edetate disodium, edible ink, FD&C blue #1 aluminum lake, gelatin, glycerin, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, 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 (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."],"openfda":{},"package_label_principal_display_panel":["Package/Label Principal Display Panel COMPARE TO the active ingredients of EXTRA STRENGTH TYLENOL ® PM See side panel OUR PHARMACIST RECOMMENDED for adults Extra Strength Acetaminophen PM Acetaminophen, Diphenhydramine HCl actual size Pain Reliever/Nighttime Sleep-Aid Non-Habit Forming 50 GELTABS acetaminophen pm image"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Pain reliever Nighttime sleep-aid"],"questions":["Questions or comments? 1-800-632-6900"],"set_id":"9c145df0-b261-469f-9494-7c1ffbfedd9c","spl_product_data_elements":["acetaminophen pm Acetaminophen, Diphenhydramine HCl ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CROSPOVIDONE (15 MPA.S AT 5%) D&C RED NO. 33 EDETATE DISODIUM FD&C BLUE NO. 1 GELATIN, UNSPECIFIED GLYCERIN HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POVIDONE, UNSPECIFIED STEARIC ACID TITANIUM DIOXIDE POLYETHYLENE GLYCOL, UNSPECIFIED Convex L837"],"stop_use":["Stop use and ask a doctor if • new symptoms occur • 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 These could be signs of a serious condition."],"version":"4","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 • glaucoma • trouble urinating due to an enlarged prostate gland • a breathing problem such as emphysema or chronic bronchitis 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 • new symptoms occur • 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 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"]}