{
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"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": "2026-06-09",
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{
"spl_product_data_elements": [
"Cramp Tabs acetaminophen, pamabrom, and pyrilamine maleate ACETAMINOPHEN ACETAMINOPHEN PAMABROM BROMOTHEOPHYLLINE PYRILAMINE MALEATE PYRILAMINE STARCH, CORN CROSCARMELLOSE SODIUM CROSPOVIDONE, UNSPECIFIED FD&C BLUE NO. 1 ALUMINUM LAKE FD&C RED NO. 40 ALUMINUM LAKE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE, UNSPECIFIED SHELLAC SILICON DIOXIDE STEARIC ACID TALC TITANIUM DIOXIDE 44;679"
],
"spl_unclassified_section": [
"Drug Facts"
],
"active_ingredient": [
"Active ingredient (In Each Caplet) Purpose Acetaminophen 500mg pain reliever/fever reducer Pamabrom 25mg diuretic Pyrilamine maleate 15 mg Antihistamine"
],
"active_ingredient_table": [
"
"
],
"indications_and_usage": [
"Use for the temporary relief of these symptoms associated with menstrual periods: headache bloating cramps backache muscular aches muscular aches irritability water-weight gain"
],
"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. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis liver disease glaucoma Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin When using this product drowsiness may occur avoid alcoholic beverages excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present 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. 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 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 difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis liver disease glaucoma"
],
"ask_doctor_or_pharmacist": [
"Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers taking the blood thinning drug warfarin"
],
"when_using": [
"When using this product drowsiness may occur avoid alcoholic beverages excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery"
],
"stop_use": [
"Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition."
],
"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, 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 do not take more than directed adults and children 12 years and over: take 2 caplets with water every 6 hours as needed do not exceed 6 caplets in a 24 hour period or as directed by a doctor children under 12 years: ask a doctor"
],
"storage_and_handling": [
"Other Information store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) avoid excessive heat and humidity tamper-evident sealed packets do not use if packet opened or torn"
],
"inactive_ingredient": [
"Inactive Ingredients corn starch, croscarmellose sodium, crospovidone, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, shellac wax, silicon dioxide, stearic acid, talc, titanium dioxide"
],
"questions": [
"Questions? 1-866-651-3660 Monday-Friday 8:00am-5:00pm EST"
],
"package_label_principal_display_panel": [
"PRINCIPAL DISPLAY PANEL - 2 Capsule Packet Box This product is not manufactured or distributed by Chattanooga Medicine Company Owner of the registered trademark Pamprin ® . Product #1472 Cramp Tabs Pain Reliever/Fever Reducer Diurectic, Antihistamine Active ingredient: Acetaminophen Pamabrom, Pyrilamine maleate Helps relieve minor aches, pains and water retention associated with the menstrual period These quality comfort tablets are formulated and packaged for use in the workplace and meet ANSI Z308.1-2021 standards. They are sealed in tamper-evident packets for safety and convenience. 80 Caplets ∙ 2 Caplets Per Packet Principal Display Panel - 2 Capsule Packet Box"
],
"set_id": "c090807d-03b7-42d4-be41-f6240a3b330f",
"id": "b218aed4-09d3-430b-b0be-64b7fcec1ab7",
"effective_time": "20241004",
"version": "1",
"openfda": {
"application_number": [
"M027"
],
"brand_name": [
"Cramp Tabs"
],
"generic_name": [
"ACETAMINOPHEN, PAMABROM, AND PYRILAMINE MALEATE"
],
"manufacturer_name": [
"JHK DBA American Safety & First Aid"
],
"product_ndc": [
"73598-1472"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"ORAL"
],
"substance_name": [
"ACETAMINOPHEN",
"PAMABROM",
"PYRILAMINE MALEATE"
],
"spl_id": [
"b218aed4-09d3-430b-b0be-64b7fcec1ab7"
],
"spl_set_id": [
"c090807d-03b7-42d4-be41-f6240a3b330f"
],
"package_ndc": [
"73598-1472-1"
],
"is_original_packager": [
true
],
"unii": [
"362O9ITL9D",
"UA8U0KJM72",
"R35D29L3ZA"
]
}
}
]
}