{ "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": 5 } }, "results": [ { "spl_product_data_elements": [ "Dologesic DF Acetaminophen, Dexbrompheniramine Maleate HYDROXYPROPYL METHYLCELLULOSE GLYCERIN TRICALCIUM PHOSPHATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A CORN ACETAMINOPHEN ACETAMINOPHEN DEXBROMPHENIRAMINE MALEATE DEXBROMPHENIRAMINE LLORENS" ], "active_ingredient": [ "Active Ingredients (in each caplet) Acetaminophen 500 mg Dexbrompheniramine Maleate 1 mg" ], "purpose": [ "Purpose Pain reliever/fever reducer antihistamine" ], "indications_and_usage": [ "Uses For the temporary relief of minor aches and pains associated with headache muscular aches backaches minor arthritis pain common cold toothaches menstrual cramps temporarily reduces fever itchy and watery eyes due to hay fever" ], "warnings": [ "Warnings Liver Warning: This product contains acetaminophen. Sever liver damage may occur if you take more than 8 capsules in 24 hours, which is the maximum daily amount with other drugs containing acetaminphen 3 or more alcoholic drinks every day while using this product Allergy Alert: Acetaminophen may cause sever skin reactions. Symptoms may incloude skin reddening blister rash. If a skin reaction occurs, stop and seek medical help right away. While using this product drosiness may occur;alcohol, sedatives, and tranquilizers may increase drowsiness effect avoid alcoholic beverages do not take this product if you are taking sedatives or transquilizers without consulting your doctor use caution when driving a motor vehicle or operating machinery Do not use with any other drug containing acetaminphen (prescription or non-prescription). If you are not sure whether a drug contains acetaminphen ask a doctor or pharmacist if you are allergic to acetaminophen or any of the inactive ingredients in the product for more than 10 days for pain, unless directed by a doctor for more than 3 days for fever, unless directed by a doctor Ask a doctor before use: if you have liver disease if you are taking the blood thinning drug warafin Stop using this product and ask a doctor if: pain gets worse or last more than 10 days fever gets worse or last more than 3 days new symptoms occur redness or swelling is present these could be signs of a serious condition" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children" ], "pregnancy_or_breast_feeding": [ "If you are pregnant or breast-feeding, ask a health professional before use." ], "dosage_and_administration": [ "Directions Overdose Warning: Taking more than recommended dose (overdose), may cause liver damage. In case of accidental overdose, contact a physician or Poison Control Center 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 exceed recommended dosage Age Dose adults and children 12 years of age and over Take 2 caplets every 4-6 hours. Do not take more than 8 caplets in 24 hours, or as directed by a doctor children under 12 years of age Do not use in children under 12 years of age. This will provide more than the recommended dose (overdose) of acetaminphen and could cause liver damage" ], "dosage_and_administration_table": [ "
AgeDose
adults and children 12 years of age and overTake 2 caplets every 4-6 hours. Do not take more than 8 caplets in 24 hours, or as directed by a doctor
children under 12 years of age Do not use in children under 12 years of age. This will provide more than the recommended dose (overdose) of acetaminphen and could cause liver damage
" ], "inactive_ingredient": [ "Inactive ingredients glycerin, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, tricalcium phosphate" ], "questions": [ "Questions or comments 1-866-595-5598" ], "recent_major_changes": [ "Added \"itchy and watery eyes due to hay fever\" in Uses" ], "package_label_principal_display_panel": [ "Dologesic" ], "set_id": "55768b45-fd98-4779-85b6-6a50c628677e", "id": "47460679-895e-b4d5-e063-6394a90ab919", "effective_time": "20251231", "version": "7", "openfda": { "application_number": [ "M012" ], "brand_name": [ "Dologesic DF" ], "generic_name": [ "ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE" ], "manufacturer_name": [ "Llorens Pharmaceutical International Division" ], "product_ndc": [ "54859-010" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "DEXBROMPHENIRAMINE MALEATE" ], "rxcui": [ "1798453" ], "spl_id": [ "47460679-895e-b4d5-e063-6394a90ab919" ], "spl_set_id": [ "55768b45-fd98-4779-85b6-6a50c628677e" ], "package_ndc": [ "54859-010-01" ], "is_original_packager": [ true ], "upc": [ "0354859010018" ], "unii": [ "362O9ITL9D", "BPA9UT29BS" ] } } ] }