{"active_ingredient":["Active Ingredients (in each 5 mL) Purpose Pyrilamine Maleate 16 mg Antihistamine Phenylephrine HCl 5 mg Nasal Decongestant"],"active_ingredient_table":["<table width=\"65%\" styleCode=\"Noautorules\"> <col width=\"60%\" align=\"left\" valign=\"top\"/> <col width=\"40%\" align=\"right\" valign=\"top\"/> <thead> <tr> <th> <content styleCode=\"italics\">Active Ingredients (in each 5 mL)</content> </th> <th> <content styleCode=\"italics\">Purpose</content> </th> </tr> </thead> <tbody> <tr> <td>Pyrilamine Maleate 16 mg</td> <td>Antihistamine</td> </tr> <tr> <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 glaucoma a breathing problem such as asthma, chronic bronchitis or emphysema trouble urinating due to an enlarged prostate gland"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you have you or your child are taking sedatives or tranquilizers"],"do_not_use":["may cause excitability, especially in children do not use if you are 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 our prescription drug contains an MAOI, ask a doctor or pharmacist before you take this product."],"dosage_and_administration":["Directions take every 6 hours. Do not take more than 4 doses in 24 hours or as directed by a doctor. Age Dose Adults and children 12 years of age and older 1 to 2 teaspoonfuls Children 6 to under 12 years of age 1 teaspoonful Children under 6 years of age As directed by a physician"],"dosage_and_administration_table":["<table frame=\"border\" width=\"75%\"> <col align=\"left\" width=\"15%\"/> <col align=\"left\" width=\"15%\"/> <tbody> <tr styleCode=\"Botrule Toprule Lrule Rrule\"> <th styleCode=\"Botrule Toprule Lrule Rrule\">Age</th> <th styleCode=\"Botrule Toprule Lrule Rrule\">Dose</th> </tr> <tr styleCode=\"Botrule Toprule Lrule Rrule\"> <td styleCode=\"Botrule Toprule Lrule Rrule\">Adults and children 12 years of age and older</td> <td styleCode=\"Botrule Toprule Lrule Rrule\">1 to 2 teaspoonfuls</td> </tr> <tr styleCode=\"Botrule Toprule Lrule Rrule\"> <td styleCode=\"Botrule Toprule Lrule Rrule\">Children 6 to under 12 years of age</td> <td styleCode=\"Botrule Toprule Lrule Rrule\">1 teaspoonful</td> </tr> <tr styleCode=\"Botrule Toprule Lrule Rrule\"> <td styleCode=\"Botrule Toprule Lrule Rrule\">Children under 6 years of age</td> <td styleCode=\"Botrule Toprule Lrule Rrule\">As directed by a physician</td> </tr> </tbody> </table>"],"effective_time":"20180912","id":"d68b7a78-c33e-49a1-9be5-258a6ed7a018","inactive_ingredient":["Inactive ingredients Artificial Grape Flavor, Citric Acid, FD&C Blue #1, FD&C Red #40, Glycerin, Hydrochloric Acid, Magnesium Aluminum Silicate, Methylparaben, Potassium Sorbate, Purified Water, Sodium Benzoate, Sodium Citrate Dihydrate,Sodium Saccharin, Sucrose and Xanthan Gum."],"indications_and_usage":["Uses temporary relief of sneezing itchy nose or throat runny nose itchy, watery eyes due to hay fever or upper respiratory allergies nasal and sinus congestion due to the common cold."],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222"],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label NDC 42192-521-16 Pyrilamine- Phenylephrine Suspension Antihistamine Nasal Decongestant Grape Bubblegum Flavor SHAKE WELL 16 fl oz (473 mL) Acella PHARMACEUTICALS, LLC PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label"],"pregnancy_or_breast_feeding":["If pregnant or breastfeeding, ask a health professional before use."],"purpose":["Active Ingredients (in each 5 mL) Purpose Pyrilamine Maleate 16 mg Antihistamine Phenylephrine HCl 5 mg Nasal Decongestant"],"purpose_table":["<table width=\"65%\" styleCode=\"Noautorules\"> <col width=\"60%\" align=\"left\" valign=\"top\"/> <col width=\"40%\" align=\"right\" valign=\"top\"/> <thead> <tr> <th> <content styleCode=\"italics\">Active Ingredients (in each 5 mL)</content> </th> <th> <content styleCode=\"italics\">Purpose</content> </th> </tr> </thead> <tbody> <tr> <td>Pyrilamine Maleate 16 mg</td> <td>Antihistamine</td> </tr> <tr> <td>Phenylephrine HCl 5 mg</td> <td>Nasal Decongestant</td> </tr> </tbody> </table>"],"questions":["Questions or comments 1-800-541-4802"],"set_id":"1089fc64-2296-4c80-a0db-efd50e693a25","spl_product_data_elements":["Pyrilamine-Phenylephrine Pyrilamine Maleate and Phenylephrine Hydrochloride CITRIC ACID MONOHYDRATE FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN HYDROCHLORIC ACID MAGNESIUM ALUMINUM SILICATE METHYLPARABEN POTASSIUM SORBATE WATER SODIUM BENZOATE TRISODIUM CITRATE DIHYDRATE SACCHARIN SODIUM SUCROSE XANTHAN GUM PYRILAMINE MALEATE PYRILAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE"],"spl_unclassified_section":["Questions or comments Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30009 Rev. 0812"],"stop_use":["Stop use and ask a doctor if nervousness, dizziness or sleeplessness occurs symptoms do not improve within 7 days or occur with a fever"],"storage_and_handling":["Other information store at 20 - 25ºC (68 - 77ºF), excursions permitted between 15 - 30ºC (between 59 - 86ºF) Tamper Evident: Do not use if seal is broken or missing."],"version":"4","warnings":["Warnings may cause excitability, especially in children do not use if you are 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 our prescription drug contains an MAOI, ask a doctor or pharmacist before you take this product. Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes glaucoma a breathing problem such as asthma, chronic bronchitis or emphysema trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you have you or your child are taking sedatives or tranquilizers When using this product do not exceed recommended dosage drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness or sleeplessness occurs symptoms do not improve within 7 days or occur with a fever If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222"],"when_using":["When using this product do not exceed recommended dosage drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery"]}