{"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) adults and children 12 years and over • take 2 caplets at bedtime • do not take more than 2 caplets of this product in 24 hours children under 12 years do not use"],"dosage_and_administration_table":["
adults and children 12 years and over• take 2 caplets at bedtime• do not take more than 2 caplets of this product in 24 hours
children under 12 yearsdo not use
"],"effective_time":"20241217","id":"bef8542c-67a4-4d65-8c1b-b3db699efffe","inactive_ingredient":["Inactive ingredients FD&C blue no. 1, FD&C blue no. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polyvinylpyrrolidone K30, pregelatinized starch, stearic acid powder, 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 (1-800-222-1222) right away."],"openfda":{"application_number":["M012"],"brand_name":["Kroger EXTRA STRENGTH Acetaminophen PM Caplet"],"generic_name":["ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["The Kroger Co."],"package_ndc":["59450-174-05","59450-174-01","59450-174-20"],"product_ndc":["59450-174"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1092189"],"spl_id":["bef8542c-67a4-4d65-8c1b-b3db699efffe"],"spl_set_id":["24a75ffa-c2a7-71a9-e063-6394a90a0e25"],"substance_name":["ACETAMINOPHEN","DIPHENHYDRAMINE HYDROCHLORIDE"],"unii":["362O9ITL9D","TC2D6JAD40"],"upc":["0041260013133"]},"package_label_principal_display_panel":["Packaging Kroger-174 Kroger-174"],"purpose":["Purpose Pain reliever Nighttime sleep aid"],"questions":["Questions or comments? Call 1-800-632-6900"],"set_id":"24a75ffa-c2a7-71a9-e063-6394a90a0e25","spl_product_data_elements":["Kroger EXTRA STRENGTH Acetaminophen PM Caplet Acetaminophen, Diphenhydramine hydrochloride ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FD&C BLUE NO. 1 FD&C BLUE NO. 2 HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 400 POVIDONE K30 STARCH, CORN STEARIC ACID TITANIUM DIOXIDE S525"],"spl_unclassified_section":["Drug Facts","Kroger ® health COMPARE TO THE ACTIVE INGREDIENTS OF TYLENOL ® PM EXTRA STRENGTH* NON-HABIT FORMING READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION *Tylenol ® is a registered trademark of Kenvue Inc. PROUDLY DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 PRODUCT OF INDIA #OUR PHARMACIST RECOMMENDED Our Brands. Our Guarantee. Love It or Your Money Back. www.kroger.com TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING For More Product Information, Scan UPC Using Your Kroger App or Call 800-632-6900"],"storage_and_handling":["Other information • store at room temperature between 20º-25ºC (68º-77ºF) • protect from light, heat and moisture"],"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 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 pharmacist before use if you are • taking the blood thinning drug warfarin • taking sedatives and 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 a serious underlying medical illness • pain gets worse or lasts more than 10 days • fever gets worse or lats 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 (1-800-222-1222) right away."]}