{"active_ingredient":["ACTIVE INGREDIENT (in each tablet) Acetaminophen 325 mg"],"dosage_and_administration":["DIRECTIONS Do not take more than directed Age Dose Adults and Children 12 years and over Take 2 tablets every 4 to 6 hours while symptoms last Do not take more than 12 tablets in 24 hours Children 6-11 years Take 1 tablet every 4 to 6 hours while symptoms last Do not take more than 5 tablets in 24 hours Children under 6 years Do not use adult Regular Strength products in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage."],"dosage_and_administration_table":["<table frame=\"void\" width=\"638\" ID=\"i5c4f2b0e-13b7-4aed-8acb-1fe8bd1bfdee\"> <thead> <tr> <td styleCode=\"BotruleLruleRruleToprule\" align=\"center\" valign=\"top\"> <content styleCode=\"bold\">Age</content> </td> <td styleCode=\"BotruleLruleRruleToprule\" align=\"center\" valign=\"top\"> <content styleCode=\"bold\">Dose</content> </td> </tr> </thead> <tbody> <tr> <td styleCode=\"BotruleLruleRruleToprule\" align=\"left\" valign=\"top\"> <content styleCode=\"bold\">Adults and Children 12</content> <content styleCode=\"bold\">   </content> <content styleCode=\"bold\">years and over</content> </td> <td styleCode=\"BotruleLruleRruleToprule\" align=\"left\" valign=\"top\"> <list listType=\"unordered\" styleCode=\"Disc\" ID=\"i19df1781-49a1-4e09-8b80-d2aa5bdf4b6e\"> <item>Take 2 tablets every 4 to 6 hours while symptoms last</item> <item>Do not take more than 12 tablets in 24 hours</item> </list> </td> </tr> <tr> <td styleCode=\"BotruleLruleRruleToprule\" align=\"left\" valign=\"top\"> <content styleCode=\"bold\">Children 6-11 years</content> </td> <td styleCode=\"BotruleLruleRruleToprule\" align=\"left\" valign=\"top\"> <list listType=\"unordered\" styleCode=\"Disc\" ID=\"i8a7715d1-4540-4713-81d7-459fe0f10d85\"> <item>Take 1 tablet every 4 to 6 hours while symptoms last</item> <item>Do not take more than 5 tablets in 24 hours</item> </list> </td> </tr> <tr> <td styleCode=\"BotruleLruleRruleToprule\" align=\"left\" valign=\"top\"> <content styleCode=\"bold\">Children under 6 years</content> </td> <td styleCode=\"BotruleLruleRruleToprule\" align=\"left\" valign=\"top\">Do not use adult Regular Strength products in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.</td> </tr> </tbody> </table>"],"effective_time":"20091216","id":"afda5f51-4b06-44ef-b730-be5a86ffb097","inactive_ingredient":["INACTIVE INGREDIETNS Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid Questions? To report a Serious Adverse Event contact 1-877-835-5472. *This product is not manufactured or distributed by McNeil Consumer Products Co., owners of the registered trademark Tylenol ® . Distributed by: Amneal Pharmaceuticals 104 Hippocrates Way, Glasgow, KY 42141 Rev. 11/2009 Relabeling of \"Additional Barcode Label\" by: Physicians Total Care, Inc. Tulsa, OK 74146"],"indications_and_usage":["USES for the temporary relief of 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."],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{},"overdosage":["OVERDOSAGE Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Acetaminophen Tablets 325 mg Bottles of 50 NDC 54868-0548-2 Bottles of 100 NDC 54868-0548-4 Bottles of 1000 NDC 54868-0548-3 image of 325 mg package label"],"package_label_principal_display_panel_table":["<table width=\"30%\" ID=\"i6b2c8d01-682b-45d1-85dc-9b406ea085d3\"> <tbody> <tr> <td>Bottles of 50  </td> <td>NDC 54868-0548-2  </td> </tr> <tr> <td>Bottles of 100  </td> <td>NDC 54868-0548-4  </td> </tr> <tr> <td>Bottles of 1000  </td> <td>NDC 54868-0548-3  </td> </tr> </tbody> </table>"],"purpose":["PURPOSES Pain Reliever/Fever Reducer"],"set_id":"bb2975ce-2330-4922-b5ea-ad86a979fbab","spl_product_data_elements":["Acetaminophen Acetaminophen ACETAMINOPHEN ACETAMINOPHEN POVIDONE STARCH, CORN SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID GPI;A325"],"spl_unclassified_section":["*Compared to the active ingredient in Tylenol ® Drug Facts","OTHER INFORMATION Store at room temperature 15°-30°C (59°-86°F) Use by expiration date on package."],"version":"2","warnings":["WARNINGS Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult takes more than 12 tablets in 24 hours, which is the maximum daily amount child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product 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. if you are allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if the user has liver disease. Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin. Stop use and ask a doctor if Pain gets worse or lasts more than 10 days in adults and children 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Keep out of reach of children."]}