{
"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": "2026-06-02",
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{
"spl_product_data_elements": [
"Buscapina Acetaminophen, Caffeine, Pyrilamine Maleate SILICON DIOXIDE STARCH, CORN MAGNESIUM STEARATE POVIDONE K30 STEARIC ACID HYPROMELLOSE, UNSPECIFIED PYRILAMINE MALEATE PYRILAMINE TALC MICROCRYSTALLINE CELLULOSE ACETAMINOPHEN ACETAMINOPHEN SODIUM STARCH GLYCOLATE TYPE A CAFFEINE CAFFEINE POLYETHYLENE GLYCOL, UNSPECIFIED TITANIUM DIOXIDE V1"
],
"spl_unclassified_section": [
"Drug Facts"
],
"active_ingredient": [
"Active ingredients Purpose Active Ingredients (in each caplet) Purpose Acetaminophen 500mg Pain reliever Caffeine 60mg Diuretic Pyrilamine maleate 15mg Antihistamine"
],
"active_ingredient_table": [
"
Active Ingredients (in each caplet)
Purpose
Acetaminophen 500mg
Pain reliever
Caffeine 60mg
Diuretic
Pyrilamine maleate 15mg
Antihistamine
"
],
"purpose": [
"Purpose Active Ingredients (in each caplet) Purpose Acetaminophen 500mg Pain reliever Caffeine 60mg Diuretic Pyrilamine maleate 15mg Antihistamine"
],
"purpose_table": [
"
Active Ingredients (in each caplet)
Purpose
Acetaminophen 500mg
Pain reliever
Caffeine 60mg
Diuretic
Pyrilamine maleate 15mg
Antihistamine
"
],
"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 caplets 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 alert 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 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 allertgic reaction to this product or any of its ingredients 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 a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers 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 about as much caffeine as a cup of coffee. 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 If pregnant or breast-feeding ask a health professional before use. Keep out of reach of chlidren. In case of overdose, get medical help or contact a Poison Control Center right away. Quick 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 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 allertgic 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 about 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 chlidren. In case of overdose, get medical help or contact a Poison Control Center 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 caplets with water. Repeat every 6 hours as needed. Do not exceed 6 caplets per day. children under 12 years: consult a doctor"
],
"storage_and_handling": [
"Other information store at room temperature 68-77°F (20-25°C) TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING"
],
"inactive_ingredient": [
"Inactive ingredients colloidal silicon dioxide, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, pvp K-30, sodium starch glycolate, stearic acid, talc, titanium dioxide"
],
"questions": [
"Questions or comments? Call toll free 619-600-5632 Monday through Friday 9AM - 5PM EST"
],
"package_label_principal_display_panel": [
"Buscapina 6 caplets Buscapina Acetaminophen, Caffeine, Pyrilamine Maleate Tablets NDC 69729-132-06 Cramps Bloating Fatigue Heacache Backache 6 Caplets 3 packs of 2 Caplets Buscapina w6"
],
"set_id": "048c4b03-1cf4-b724-e063-6294a90a1cad",
"id": "285fd0a2-df05-22b1-e063-6394a90a6962",
"effective_time": "20241203",
"version": "2",
"openfda": {
"application_number": [
"M013"
],
"brand_name": [
"Buscapina"
],
"generic_name": [
"ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE"
],
"manufacturer_name": [
"OPMX LLC"
],
"product_ndc": [
"69729-132"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"ORAL"
],
"substance_name": [
"ACETAMINOPHEN",
"CAFFEINE",
"PYRILAMINE MALEATE"
],
"rxcui": [
"1597298"
],
"spl_id": [
"285fd0a2-df05-22b1-e063-6394a90a6962"
],
"spl_set_id": [
"048c4b03-1cf4-b724-e063-6294a90a1cad"
],
"package_ndc": [
"69729-132-06"
],
"is_original_packager": [
true
],
"upc": [
"0810053181249"
],
"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"
]
}
}
]
}