{"active_ingredient":["Active ingredient Drug Facts 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":"20200519","id":"2b03c3d4-74a3-418e-9dec-c367fa1effde","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":["Keep Out of Reach of Children Keep out of reach of children."],"openfda":{},"package_label_principal_display_panel":["Package/Label Principal Display Panel Acephen Acetaminophen Suppositories USP 650 mg 10 Rectal Suppositories bag label"],"purpose":["Purpose Pain reliever/fever reducer"],"set_id":"d0469b34-486f-451f-9319-48771df6857a","spl_product_data_elements":["Acephen Acetaminophen ACETAMINOPHEN ACETAMINOPHEN GLYCERYL MONOSTEARATE HYDROGENATED CASTOR OIL PEG-100 STEARATE SORBITAN MONOOLEATE"],"spl_unclassified_section":["Storage Store at Room Temperature 15-30 C (59-86 F) TAMPER-EVIDENT: Individually sealed in foil for your protection. Do not use if foil is torn or open.","Other Information Established since 1919, G&W Laboratories, Inc. is one of the largest manufacturers of quality suppositories in the United States. We take special care to ensure that all products are of the finest quality you can buy. SATISFACTION GUARANTEED OR YOUR MONEY BACK FROM G&W G & W Laboratories, Inc. 111 Coolidge Street South Plainfield, NJ 07080 Visit our website @ www.gwlabs.com Questions? call 1-800-922-1038 G&W and ACEPHEN are trademarks owned by their respective owners. Distributed by: Cardinal Health Dublin, OH 43017 L3299120-10218 L3299120-20218"],"version":"12","warnings":["Warnings If pregnant or breast-feeding, ask a health professional before use. 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. WARNINGS: For rectal use only Liver warning: This product contains acetaminophen. Severe liver damage may occur if -an adult or child 12 years or 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 -if 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."]}