{ "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": "2026-08-11", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "spl_product_data_elements": [ "Menstrual Complete Menstrual Complete SILICON DIOXIDE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE STARCH, PREGELATINIZED CORN TITANIUM DIOXIDE TALC HYPROMELLOSES POLYETHYLENE GLYCOL 400 POVIDONE ACETAMINOPHEN ACETAMINOPHEN CAFFEINE CAFFEINE PYRILAMINE MALEATE PYRILAMINE" ], "active_ingredient": [ "Drug Facts Maximum Strength Menstrual Complete / Buscapina", "Active ingredients (in each Caplet) Acetaminophen 500mg Caffeine 60mg Pyrilamine maleate 15mg" ], "purpose": [ "Purpose Pain Reliever, Diuretic, Antihistamine, Multi-Symptom Relief" ], "indications_and_usage": [ "Uses For the temporary relief of these symptoms associated with menstrual periods Cramps Bloating Water- weight gain Headache Backache Muscle aches Fatigue" ], "warnings": [ "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 6 tablets in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product. Allergy warning: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: skin reddening blisters rash hives facial swelling asthma (wheezing) shock If a skin or general allergic reaction occurs, stop use and seek medical help right away." ], "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. 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 Glaucoma difficulty in urination due to enlargement of the 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" ], "when_using": [ "When using this product you may get drowsy avoid alcoholic drinks excitability may occur, especially in children alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery limit the use of caffeine-containing medications, foods or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally rapid heartbeat. The recommended dose of this product contains aboout as much caffeine as a cup of coffee." ], "stop_use": [ "Stop use and ask a doctor if new symptoms appear redness or swelling is present pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days" ], "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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick 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 exceed recommended dosage. Adults and children 12 years and over: Take 2 tablets with water. Repeat every 6 hours, as needed. Do not exceed 6 tablets per day Children under 12 years: Consult a doctor" ], "questions": [ "Other Information Store at room temperature TAMPER EVIDENT; DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING", "Questions or comments? Call toll free 1-844-832-1138 Monday through Friday 9AM - 5PM or www.healthlifeofusa.com" ], "inactive_ingredient": [ "Inactive ingredients Colloidal silicon dioxide Hypromellose Magnesium stearate Microcrystalline cellulose Polyethylene glycol Polyvinyl pyrrolidone Pregelatinized starch Titanium dioxide Talc" ], "package_label_principal_display_panel": [ "Maximum Strength Menstrual Complete Acetaminophen 500mg Caffeine 60mg Pyrilamine maleate 15mg 20 Caplets Compare to Midol® Complete active ingredient Distributed by: Healthlife of USA LLC Rahway NJ 07065 www.healthlifeofusa.com 11233", "Buscapina Acetaminophen 500mg Caffeine 60mg Pyrilamine maleate 15mg 24 Caplets Distributed By: OPMX San Diego, CA, 92154 image description" ], "set_id": "c7e89b01-a8eb-4487-8f0b-a4b9ae6d9f33", "id": "08343e8a-faa7-79f6-e063-6294a90a4417", "effective_time": "20231021", "version": "9", "openfda": { "application_number": [ "M013" ], "brand_name": [ "Menstrual Complete" ], "generic_name": [ "MENSTRUAL COMPLETE" ], "manufacturer_name": [ "Healthlife of USA" ], "product_ndc": [ "69517-130" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "CAFFEINE", "PYRILAMINE MALEATE" ], "rxcui": [ "1597298" ], "spl_id": [ "08343e8a-faa7-79f6-e063-6294a90a4417" ], "spl_set_id": [ "c7e89b01-a8eb-4487-8f0b-a4b9ae6d9f33" ], "package_ndc": [ "69517-130-20", "69517-130-24" ], "is_original_packager": [ true ], "nui": [ "N0000175739", "N0000175729", "N0000175790", "M0023046" ], "pharm_class_epc": [ "Central Nervous System Stimulant [EPC]", "Methylxanthine [EPC]" ], "pharm_class_pe": [ "Central Nervous System Stimulation [PE]" ], "pharm_class_cs": [ "Xanthines [CS]" ], "unii": [ "362O9ITL9D", "3G6A5W338E", "R35D29L3ZA" ] } } ] }