{ "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": 1 } }, "results": [ { "spl_product_data_elements": [ "Pain Relief PM Extra Strength Acetaminophen 500 mg and Diphenhydramine HCl 25 mg ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CROSCARMELLOSE SODIUM FD&C BLUE NO. 1 HYPROMELLOSES MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 1000 POVIDONE STARCH, CORN SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE CARNAUBA WAX FD&C BLUE NO. 2 POLYSORBATE 80 G651" ], "active_ingredient": [ "Active ingredients (in each caplet) Acetaminophen 500 mg Diphenhydramine HCl 25 mg" ], "purpose": [ "Purpose Pain reliever Nighttime sleep aid" ], "indications_and_usage": [ "Uses temporarily relief of occasional headaches and minor aches and pains with accompanying sleeplessness" ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4000 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 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. You may report side effects to 1-888-952-0050" ], "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" ], "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 if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers" ], "when_using": [ "When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery" ], "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. You may report side effects to 1-888-952-0050" ], "pregnancy_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, contact a doctor or 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 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" ], "inactive_ingredient": [ "Inactive Ingredients croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glylcol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide May contain: carnauba wax, FD&C blue #2 aluminum lake, polysorbate 80" ], "package_label_principal_display_panel": [ "Package/Label Principal Display Panel Pain Relief Label Pain Relief Pain Relief Label Pain Relief" ], "set_id": "423a8445-964c-4cdb-889a-f391ca5253e7", "id": "d525d4d3-adac-40fb-a927-832f7d6a831b", "effective_time": "20181231", "version": "6", "openfda": { "application_number": [ "M013" ], "brand_name": [ "Pain Relief PM Extra Strength" ], "generic_name": [ "ACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MG" ], "manufacturer_name": [ "Allegiant Health" ], "product_ndc": [ "69168-393" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "DIPHENHYDRAMINE HYDROCHLORIDE" ], "rxcui": [ "1092189" ], "spl_id": [ "d525d4d3-adac-40fb-a927-832f7d6a831b" ], "spl_set_id": [ "423a8445-964c-4cdb-889a-f391ca5253e7" ], "package_ndc": [ "69168-393-02", "69168-393-24", "69168-393-50", "69168-393-99", "69168-393-26" ], "is_original_packager": [ true ], "upc": [ "0369168267992" ], "unii": [ "362O9ITL9D", "TC2D6JAD40" ] } } ] }