{ "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", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Acetaminophen Oral Solution Acetaminophen 160mg/5mL WATER SUCRALOSE ANHYDROUS CITRIC ACID POLYETHYLENE GLYCOL 350 PROPYLENE GLYCOL METHYLPARABEN PROPYLPARABEN SODIUM CITRATE ACETAMINOPHEN ACETAMINOPHEN" ], "active_ingredient": [ "Active ingredient (in each 5 mL-teaspoonful) Acetaminophen 160mg" ], "purpose": [ "Purpose Pain reliever/fever reducer" ], "indications_and_usage": [ "Uses Temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache premenstrual and menstrual cramps temporarily reduces fever" ], "warnings": [ "Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if: if adults takes more than 6 doses in 24 hours, which is the maximum daily amount child takes more than 5 doses in 24 hours, which is the maximum daily amount taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks everyday while using the 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": [ "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." ], "ask_doctor": [ "Ask a doctor before use if your child has liver disease" ], "ask_doctor_or_pharmacist": [ "Ask a doctor before use if you have taking the blood thinning drug warfarin." ], "when_using": [ "When using this product do not exceed recommended dose" ], "stop_use": [ "Stop use and ask a doctor if pain gets worse or lasts more than 10 days in adults 5 days pain gets worse or lasts more than 5 days in children under 12 years 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." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of overdose, get medical help or conbtact a Poison Control Center right away. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding ask a health professional before use" ], "dosage_and_administration": [ "Directions find dose in chart below if possible, use weight to dose, otherwise use age dosage may be repeated every 4 hours, or as directed by a doctor do not give more than 5 doses in 24 hours Weight (lbs) Weight (lbs) Weight (lbs) Weight (lbs) Weight (lbs) Weight (lbs) Weight (lbs) Weight (lbs) Age (years) Under 2 2 to 3 4 to 5 6 to 8 9 to 10 11 12 to adult Dosage teaspoonful (tsp) consult Physician 1 tsp (5 ml) 1 1/2 tsp (7.5ml) 2 tsp (10 ml) 2 1/2 tsp (12.5ml) 3 tsp (15 ml) 4 tsp (20 ml)" ], "dosage_and_administration_table": [ "
Weight(lbs) Weight (lbs) Weight (lbs) Weight (lbs) Weight (lbs) Weight (lbs) Weight (lbs)Weight(lbs)
Age(years) Under 2 2 to 3 4 to 5 6 to 8 9 to 10 11 12 toadult
Dosageteaspoonful (tsp) consult Physician 1 tsp(5 ml) 1 1/2 tsp(7.5ml) 2 tsp(10 ml) 2 1/2 tsp(12.5ml) 3 tsp(15 ml) 4 tsp(20 ml)
" ], "other_safety_information": [ "Other information for institutional or pharmacy use only store at room temperature between 15-30°C (59-86°F) do not freezing protect from light TAMPER EVIDENT do not use if foil seal over bottle opening is torn, broken or missing" ], "inactive_ingredient": [ "Inactive Ingredient artificial and natural cherry flavor, citric acid, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose" ], "questions": [ "Question or Comments? call 305-592-9216 or info@aldamapharm.com" ], "package_label_principal_display_panel": [ "label" ], "set_id": "1a07fd53-e968-444e-b1f2-6e1f31fd4eee", "id": "51dbb29a-02c5-93b5-e063-6394a90a5552", "effective_time": "20260515", "version": "2", "openfda": { "application_number": [ "M013" ], "brand_name": [ "Acetaminophen Oral Solution" ], "generic_name": [ "ACETAMINOPHEN 160MG/5ML" ], "manufacturer_name": [ "Aldama Pharmaceuticals, Inc" ], "product_ndc": [ "73564-816" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN" ], "rxcui": [ "307675" ], "spl_id": [ "51dbb29a-02c5-93b5-e063-6394a90a5552" ], "spl_set_id": [ "1a07fd53-e968-444e-b1f2-6e1f31fd4eee" ], "package_ndc": [ "73564-816-16" ], "is_original_packager": [ true ], "unii": [ "362O9ITL9D" ] } } ] }