{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-10", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "spl_product_data_elements": [ "Pain Reliever PM, Extra Strength, 24-7 Life by 7-Eleven acetaminophen, diphenhydramine hcl tablet, film coated FD&C BLUE NO. 1 ALUMINUM LAKE MICROCRYSTALLINE CELLULOSE TITANIUM DIOXIDE TALC DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ACETAMINOPHEN ACETAMINOPHEN CROSCARMELLOSE SODIUM POLYETHYLENE GLYCOL, UNSPECIFIED STARCH, CORN POVIDONE, UNSPECIFIED SILICON DIOXIDE POLYVINYL ALCOHOL, UNSPECIFIED STEARIC ACID 44;235" ], "spl_unclassified_section": [ "Drug Facts Drug Facts", "Other information Other information store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number" ], "active_ingredient": [ "Active ingredients Active ingredients (in each caplet) Acetaminophen 500 mg Diphenhydramine HCl 25 mg Purpose Purpose Pain reliever Nighttime sleep-aid" ], "purpose": [ "Purpose Purpose Pain reliever Nighttime sleep-aid" ], "indications_and_usage": [ "Uses Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness" ], "warnings": [ "Warnings Warnings Liver warning 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 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 Do not use with any other product containing diphenhydramine, even one used on skin in children under 12 years of age with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have Ask a doctor before use if you have liver disease a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland glaucoma Ask a doctor or pharmacist before use if Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product When using this product avoid alcoholic beverages do not drive a motor vehicle or operate machinery drowsiness will occur Stop use and ask a doctor if 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. new symptoms occur redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days These could be signs of a serious condition. If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "do_not_use": [ "Do not use Do not use with any other product containing diphenhydramine, even one used on skin in children under 12 years of age with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you have ever had an allergic reaction to this product or any of its ingredients" ], "ask_doctor": [ "Ask a doctor before use if you have Ask a doctor before use if you have liver disease a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland glaucoma" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers" ], "when_using": [ "When using this product When using this product avoid alcoholic beverages do not drive a motor vehicle or operate machinery drowsiness will occur" ], "stop_use": [ "Stop use and ask a doctor if 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. new symptoms occur redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days These could be signs of a serious condition." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms." ], "dosage_and_administration": [ "Directions Directions do not take more than directed 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" ], "inactive_ingredient": [ "Inactive ingredients Inactive ingredients colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C blue #1 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, stearic acid, talc, titanium dioxide" ], "questions": [ "Questions or comments? Questions or comments? 1-844-428-2538" ], "package_label_principal_display_panel": [ "Pain Reliever PM, Extra Strength, 24/7 Life by 7-Eleven TM [ 24/7 Life by 7-Eleven logo] Extra Strength Pain Reliever PM Acetaminophen 500 mg Diphenhydramine HCl 25 mg Pain Reliever/Nighttime Sleep-Aid compare to EXTRA STRENGTH TYLENOL ® PM CAPLETS active ingredients* Non-Habit Forming 24 CAPLETS [caplet image] Actual Size [caduceus] PDP/Package/Label" ], "set_id": "45735cd8-ac07-3f12-e063-6294a90a0cb2", "id": "45735cd8-ac08-3f12-e063-6294a90a0cb2", "effective_time": "20251208", "version": "1", "openfda": { "application_number": [ "M013" ], "brand_name": [ "Pain Reliever PM, Extra Strength, 24-7 Life by 7-Eleven" ], "generic_name": [ "ACETAMINOPHEN, DIPHENHYDRAMINE HCL TABLET, FILM COATED" ], "manufacturer_name": [ "Lil' Drug Store Products, Inc." ], "product_ndc": [ "66715-5640" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "DIPHENHYDRAMINE HYDROCHLORIDE" ], "rxcui": [ "1092189" ], "spl_id": [ "45735cd8-ac08-3f12-e063-6294a90a0cb2" ], "spl_set_id": [ "45735cd8-ac07-3f12-e063-6294a90a0cb2" ], "package_ndc": [ "66715-5640-4" ], "is_original_packager": [ true ], "unii": [ "362O9ITL9D", "TC2D6JAD40" ] } } ] }