{"active_ingredient":["Drug Facts Active ingredients (in each 1 mL dropperful) ………………………… .. Purpose Pseudoephedrine Hydrochloride 10 mg ................................ Nasal decongestant Triprolidine Hydrochloride 0.938 mg .............................................. Antihistamine Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: nasal congestion reduces swelling of nasal passages runny nose sneezing itching of the nose and throat itchy, watery eyes Warnings Do not exceed recommended dosage. Do not use this product 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_doctor":["Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes difficulty in urination due to the enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis glaucoma"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers."],"effective_time":"20101229","id":"4d37134b-76ba-475f-90f9-404f514d206d","keep_out_of_reach_of_children":["Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{},"package_label_principal_display_panel":["PACKAGING NDC# 68032-461-01 Triprolidine HCl/PSE HCl 0.938 mg/10 mg/1 mL Drops Sugar Free • Alcohol Free Nasal Decongestant • Antihistamine Each dropperful (1 mL) for oral administration contains: Pseudoephedrine HCl ....................... 10 mg Triprolidine HCl ........................... 0.938 mg Cotton Candy Flavor 1 fl oz (30 mL) For Professional Use. See attached insert for complete dosage and product information. Tamper Evident by foil seal under cap. Do not use if foil seal is broken or missing. Supplied in a tight, light-resistant container with a child-resistant cap. Manufactured for: River’s Edge Pharmaceuticals, LLC Suwanee, GA 30024 Rev. 01/10 461-20 label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"questions":["Directions Do not exceed recommended dosage. Adults and children 12 years of age and over - 2.67 mL every 6 hours, not to exceed 4 doses in 24 hours. Children 6 to under 12 - 1.33 mL every 6 hours, not to exceed 4 doses in 24 hours. Children under 6 years of age - Consult a doctor. Other information Store at 59° - 86°F (15° - 30°C) Inactive ingredients Citric Acid, Cotton Candy Flavor, FDC Red #40, Glycerin, Propylene Glycol, Purified Water, Sodium Saccharin, Sodium Citrate, Sorbitol. Questions? Comments? Seek medical assistance immediately for serious side effects associated with the use of this product. Serious side effects may be reported to this number: 1-866-934-6025 (Mon-Fri 8 a.m. to 5 p.m. EST) and FDA at 1-866-934-6025, or www.fda.gov/medwatch. Rev. 01/10 461-10"],"set_id":"f5ad0d2c-bfc7-4604-a69a-1b2433ac791c","spl_product_data_elements":["Triprolidine HCl PSE HCl PSEUDOEPHEDRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE TRIPROLIDINE HYDROCHLORIDE TRIPROLIDINE CITRIC ACID MONOHYDRATE FD&C RED NO. 40 GLYCERIN PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM CITRATE SORBITOL"],"stop_use":["Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition. new symptoms occur"],"version":"11","when_using":["When using this product excitability may occur, especially in children may cause drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery"]}