{"active_ingredient":["Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever Phenylephrine HCl 5 mg Nasal decongestant"],"active_ingredient_table":["<table width=\"70%\"> <col width=\"70%\" align=\"left\" valign=\"middle\"/> <col width=\"30%\" align=\"right\" valign=\"middle\"/> <thead> <tr styleCode=\"Toprule\"> <th> <content styleCode=\"italics\">Active ingredients (in each caplet)</content> </th> <th> <content styleCode=\"italics\">Purpose</content> </th> </tr> </thead> <tbody> <tr styleCode=\"Toprule\"> <td>Acetaminophen 325 mg</td> <td>Pain reliever</td> </tr> <tr styleCode=\"Botrule\"> <td>Phenylephrine HCl 5 mg</td> <td>Nasal decongestant</td> </tr> </tbody> </table>"],"ask_doctor":["Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland"],"do_not_use":["Do not use with another product containing acetaminophen if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product."],"dosage_and_administration":["Directions do not use more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 4 hours do not take more than 12 caplets in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage"],"dosage_and_administration_table":["<table width=\"70%\"> <col width=\"50%\" align=\"left\" valign=\"top\"/> <col width=\"50%\" align=\"left\" valign=\"top\"/> <tbody> <tr styleCode=\"Botrule\"> <td styleCode=\"Lrule Rrule\">adults and children 12 years and over</td> <td styleCode=\"Rrule\"> <list listType=\"unordered\" styleCode=\"Square\"> <item>take 2 caplets every 4 hours </item> <item>do not take more than 12 caplets in 24 hours</item> </list> </td> </tr> <tr> <td styleCode=\"Lrule Rrule\">children under 12 years</td> <td styleCode=\"Rrule\">do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage</td> </tr> </tbody> </table>"],"effective_time":"20121219","id":"662817c2-e9ac-41f4-99be-3fde9c8deee0","inactive_ingredient":["Inactive ingredients carnauba wax, corn starch, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, powdered cellulose, pregelatinized starch, sodium starch glycolate, titanium dioxide"],"indications_and_usage":["Uses temporarily relieves headache, minor aches, and pains temporarily relieves nasal congestion"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Non-Drowsy SUDAFED PE ® MAXIMUM STRENGTH SINUS HEADACHE Pain reliever, Nasal decongestant contains: Acetaminophen and phenylephrine HCl Does not contain Pseudoephedrine Sinus Pain & Headache Sinus Pressure Nasal & Sinus Congestion NDC 50580-665-24 12 DOSES 2 Pills/Dose 24 COATED CAPLETS* *CAPSULE-SHAPED TABLETS PRINCIPAL DISPLAY PANEL"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever Phenylephrine HCl 5 mg Nasal decongestant"],"purpose_table":["<table width=\"70%\"> <col width=\"70%\" align=\"left\" valign=\"middle\"/> <col width=\"30%\" align=\"right\" valign=\"middle\"/> <thead> <tr styleCode=\"Toprule\"> <th> <content styleCode=\"italics\">Active ingredients (in each caplet)</content> </th> <th> <content styleCode=\"italics\">Purpose</content> </th> </tr> </thead> <tbody> <tr styleCode=\"Toprule\"> <td>Acetaminophen 325 mg</td> <td>Pain reliever</td> </tr> <tr styleCode=\"Botrule\"> <td>Phenylephrine HCl 5 mg</td> <td>Nasal decongestant</td> </tr> </tbody> </table>"],"questions":["Questions or comments? call 1-888-217-2117"],"set_id":"36fb5201-3fa8-4b46-a1f7-f9e7f42727af","spl_product_data_elements":["Sudafed PE Non-Drowsy Sinus Headache MAXIMUM STRENGTH acetaminophen and phenylephrine hydrochloride acetaminophen acetaminophen phenylephrine hydrochloride phenylephrine carnauba wax starch, corn FD&C yellow NO. 6 aluminum oxide hypromelloses magnesium stearate cellulose, microcrystalline polyethylene glycols polysorbate 80 powdered cellulose sodium starch glycolate Type A Potato titanium dioxide peach colored SU;PE;WL;89"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition."],"storage_and_handling":["Other information store between 20 - 25°C (68 - 77°F) do not use if carton is opened or if blister unit is broken see side panel for lot number and expiration date"],"version":"2","warnings":["Warnings Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers or fever reducers. Acetaminophen may cause liver damage. Do not use with another product containing acetaminophen if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland When using this product do not exceed recommended dose Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur 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. 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."],"when_using":["When using this product do not exceed recommended dose"]}