{"active_ingredient":["ACTIVE INGREDIENT (in each rectal suppository) Acetaminophen 650 mg"],"dosage_and_administration":["DIRECTIONS • do not use more than directed • remove foil wrapper • carefully insert suppository well up into rectum • adults and children 12 years and older • 1 suppository every 4 to 6 hours while symptoms persist • do not exceed 6 doses in any 24-hour period • children under 12 years: do not use"],"effective_time":"20220420","id":"dd1b0d7c-51ad-cd10-e053-2995a90af3a5","inactive_ingredient":["INACTIVE INGREDIENTS glyceryl stearate, hydrogenated vegetable oil, polyethylene glycol 100 stearate, sorbitan monooleate"],"indications_and_usage":["USES temporarily • reduces fever • relieves minor aches, pains, and headache"],"keep_out_of_reach_of_children":["OTHER INFORMATION • store at room temperature 15°-30°C (59°-86°F)"],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 0713-0165-01 G&W ACEPHEN TM Acetaminophen Suppositories USP 650 mg Pain Reliever • Fever Reducer 100 Rectal Suppositories carton_100"],"purpose":["PURPOSE Pain reliever/fever reducer"],"questions":["QUESTIONS? call 1-800-922-1038"],"set_id":"ab9a9048-75b7-904c-6683-06d7de69ec52","spl_product_data_elements":["ACEPHEN Acetaminophen GLYCERYL MONOSTEARATE HYDROGENATED COCONUT OIL PEG-100 STEARATE SORBITAN MONOOLEATE ACETAMINOPHEN ACETAMINOPHEN"],"version":"4","warnings":["WARNINGS For rectal use only Liver Warning: This product contains acetaminophen. Severe liver damage may occur if • 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. Do not use • in children under 12 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."]}