{ "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": "2026-10-02", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Feverall Jr. Strength Acetaminophen ACETAMINOPHEN ACETAMINOPHEN GLYCERYL MONOSTEARATE HYDROGENATED PALM KERNEL OIL PEG-100 STEARATE POLYSORBATE 80" ], "spl_unclassified_section": [ "Drug Facts", "Dist. by: Ohm Laboratories, Inc. New Brunswick, NJ 08901 Tamper-evident: Suppositories are individually wrapped. Do not use if imprinted wrapper is opened or damaged." ], "active_ingredient": [ "Active ingredient (in each rectal suppository) Acetaminophen, USP 325 mg" ], "purpose": [ "Purposes Pain reliever/fever reducer" ], "indications_and_usage": [ "Uses temporarily reduces fever relieves minor aches, pains, and headache" ], "warnings": [ "Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if a child 6 to 12 years takes more than 5 doses in 24 hours an adult or child 12 years and older takes more than 6 doses in 24 hours, which is the maximum daily amount taken with other drugs containing acetaminophen an adult takes 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. For rectal use only. Do not use in children under 6 years if you are allergic to acetaminophen. 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 a doctor before use if you have liver disease. you are taking the blood thinning drug warfarin. Stop use and ask a doctor if fever lasts more than 3 days (72 hours), or recurs. pain gets worse or lasts more than 10 days. new symptoms occur. redness or swelling is present in the painful area. These may be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical in case of overdose for adults and for children even if you do not notice any signs or symptoms." ], "do_not_use": [ "Do not use in children under 6 years if you are allergic to acetaminophen. 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 you have liver disease. you are taking the blood thinning drug warfarin." ], "stop_use": [ "Stop use and ask a doctor if fever lasts more than 3 days (72 hours), or recurs. pain gets worse or lasts more than 10 days. new symptoms occur. redness or swelling is present in the painful area. These may be signs of a serious condition." ], "keep_out_of_reach_of_children": [ "If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical in case of overdose for adults and for children even if you do not notice any signs or symptoms." ], "dosage_and_administration": [ "Directions do not use more than directed remove wrapper carefully insert suppository well up into the rectum Dosing Chart Age Dose under 6 years do not use 6 to 12 years Use 1 suppository every 4 to 6 hours. (maximum of 5 doses in 24 hours) adults and children 12 years and older Use 2 suppositories every 4 to 6 hours. (maximum of 6 doses)" ], "dosage_and_administration_table": [ "
Dosing Chart
AgeDose
under 6 yearsdo not use
6 to 12 yearsUse 1 suppository every 4 to 6 hours. (maximum of 5 doses in 24 hours)
adults and children 12 years and olderUse 2 suppositories every 4 to 6 hours. (maximum of 6 doses)
" ], "storage_and_handling": [ "Other information store at 2°-27°C (35°-80°F) do not use if imprinted suppository wrapper is opened or damaged" ], "inactive_ingredient": [ "Inactive ingredients glycerol monostearate, hydrogenated vegetable oil, polyoxyethylene stearate, polysorbate 80" ], "questions": [ "Questions? call 1-866-923-4914" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 325 mg Suppository Blister Pack Carton NDC 51672-2116-2 JR. STRENGTH ages 6-12 years FeverAll ® ACETAMINOPHEN SUPPOSITORIES Pain Reliever/Fever Reducer 6 Rectal Suppositories 325 mg each Carton" ], "set_id": "3561bbc3-53b0-4857-8b71-39e165ed95ce", "id": "5a99e46d-4983-579f-e063-6394a90a40db", "effective_time": "20260903", "version": "8", "openfda": { "application_number": [ "NDA018337" ], "brand_name": [ "Feverall Jr. Strength" ], "generic_name": [ "ACETAMINOPHEN" ], "manufacturer_name": [ "Sun Pharmaceutical Industries, Inc." ], "product_ndc": [ "51672-2116" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "RECTAL" ], "substance_name": [ "ACETAMINOPHEN" ], "rxcui": [ "198437", "209361" ], "spl_id": [ "5a99e46d-4983-579f-e063-6394a90a40db" ], "spl_set_id": [ "3561bbc3-53b0-4857-8b71-39e165ed95ce" ], "package_ndc": [ "51672-2116-0", "51672-2116-2", "51672-2116-4" ], "is_original_packager": [ true ], "unii": [ "362O9ITL9D" ] } } ] }