{ "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": "2026-06-09", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Redicare Non-Aspirin 500mg Redicare Non-Aspirin, Acetaminophen 500mg STARCH, CORN ACETAMINOPHEN ACETAMINOPHEN POVIDONE SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID AZ;011" ], "spl_unclassified_section": [ "Drug Facts" ], "active_ingredient": [ "Active Ingredient (in each tablet) Acetaminophen 500mg" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "indications_and_usage": [ "Uses: temporarily relieves minor aches and pains due to: ■ the common cold ■ headache ■ backache ■ minor pain of arthritis ■ toothache ■ muscular aches ■ premenstrual and menstrual cramps ■ temporarily reduces fever" ], "warnings": [ "Warnings: Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 4,000mg 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 are allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if you have liver disease Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin 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. Overdose warning: 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." ], "warnings_and_cautions": [ "Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 4,000mg of acetaminophen in 24 hours ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks every day while using this product" ], "adverse_reactions": [ "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 drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ■ if you are allergic to acetaminophen or any of the inactive ingredients in this product" ], "ask_doctor": [ "Ask a doctor before use if you have liver disease" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin" ], "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." ], "overdosage": [ "Overdose warning: 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 take more than directed (see overdose warning) Adults and children 12 years and over: ■ take 2 tablets every 6 hours while symptoms last ■ do not take more than 6 tablets in 24 hours, unless directed by a doctor ■ do not take for more than 10 days unless directed by a doctor Children under 12 years: ask a doctor" ], "storage_and_handling": [ "Other Information: ■ store between 20°-25°C (68°-77°F) ■ do not use if imprinted safety seal under cap is broken or missing" ], "inactive_ingredient": [ "Inactive Ingredients: corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid" ], "information_for_owners_or_caregivers": [ "Questions or Comments? Call 1-866-561-5650 Monday to Friday 9am-5pm EST" ], "package_label_principal_display_panel": [ "Principal Display", "Packet" ], "set_id": "2f229898-1777-732c-e063-6394a90a76bc", "id": "2f850cc1-2c48-a305-e063-6294a90a40c7", "effective_time": "20250304", "version": "2", "openfda": { "application_number": [ "M013" ], "brand_name": [ "Redicare Non-Aspirin 500mg" ], "generic_name": [ "REDICARE NON-ASPIRIN, ACETAMINOPHEN 500MG" ], "manufacturer_name": [ "Redicare LLC" ], "product_ndc": [ "71105-011" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN" ], "rxcui": [ "198440" ], "spl_id": [ "2f850cc1-2c48-a305-e063-6294a90a40c7" ], "spl_set_id": [ "2f229898-1777-732c-e063-6394a90a76bc" ], "package_ndc": [ "71105-011-01", "71105-011-02" ], "is_original_packager": [ true ], "unii": [ "362O9ITL9D" ] } } ] }