{"description":["DESCRIPTION A clear liquid having a grape flavor and odor. Each teaspoonful (5mL.) contains: Dextromethorphan Hydrobromide, USP 15 mg Chlorpheniramine Maleate, USP 4 mg Phenylephrine Hydrochloride, USP 10 mg INACTIVE INGREDIENTS Citric Acid, Glycerin, Sodium Benzoate, Sorbitol Solution, Grape Flavor and Purified Water. Phenylephrine Hydrochloride C 9 H 13 NO 2 HCl M.W. 203.67 Benzenemethanol, 3-hydroxy-α-[(methylamino)methyl]-, hydrochloride ( R )-. Chlorpheniramine Maleate C 16 H 19 CIN 2 C 4 H 4 O 4 M.W. 390.86 2-Pyridinepropanamine, γ-(4-chlorophenyl)- N, N -dimethyl-, (Z)-2-butenedioate. Dextromethorphan Hydrobromide C 18 H 25 NO • HBr • H 2 O M.W. 370.32 Morphinan, 3-Methoxy-17-methyl-, (9α, 13α, 14α)-, hydrobromide, monohydrate. Chemical Structure Chemical Structure Chemical Structure"],"description_table":["<table width=\"60%\"> <col width=\"80%\" align=\"left\" valign=\"top\"/> <col width=\"20%\" align=\"right\" valign=\"top\"/> <tbody> <tr styleCode=\"Toprule\"> <td>Dextromethorphan Hydrobromide, USP</td> <td>15 mg</td> </tr> <tr> <td>Chlorpheniramine Maleate, USP</td> <td>4 mg</td> </tr> <tr styleCode=\"Botrule\"> <td>Phenylephrine Hydrochloride, USP</td> <td>10 mg</td> </tr> </tbody> </table>"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Adults and Children 12 years of age or older One teaspoonful every four hours as needed. Children 6 to 12 years of age One-half teaspoonful every four hours as needed. Do not exceed six doses in a 24-hour period. Do not take this product for more than 7 days. This product is not indicated for use in children under 6 years of age. (see PRECAUTIONS, Pediatric Use . )"],"drug_interactions":["Drug Interactions 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 are uncertain whether your prescription drug contains an MAOI, consult a health professional before taking this product."],"effective_time":"20101028","how_supplied":["How Supplied Trital™ DM is a Sugar-Free, Alcohol-Free and Dye-Free liquid supplied in 16 fl. oz. bottles, NDC 51991-131-16. Store at 25°C (77°F); excursions permitted to 15°-30° C (59°-86°F). See USP Controlled Room Temperature Protect from freezing. Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product."],"id":"ddf4cd07-610a-4ba2-91ae-9288cdfb4fe5","indications_and_usage":["INDICATIONS For the temporary relief of cough due to minor throat and bronchial irritation as may occur with the common cold or with inhaled irritants. Temporarily relieves nasal congestion, runny nose, and sneezing due to the common cold, hay fever, or other upper respiratory allergies."],"information_for_patients":["Information for Patients Phenylephrine is banned and tested for by the U.S. Olympic Committee (USOC) and the National Collegiate Athletic Association (NCAA)."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label Breckenridge Pharmaceutical, Inc. NDC 51991-131-16 Trital ™ DM Liquid Sugar Free Dye Free Alcohol Free Description: Each 5ml (one teaspoonful) for oral administration contains: Dextromethorphan Hydrobromide, USP 15 mg Chlorpheniramine Maleate, USP 4 mg Phenylephrine Hydrochloride, USP 10 mg INACTIVE INGREDIENTS: Citric Acid, Glycerin, Sodium Benzoate, Sorbitol Solution, Grape Flavor and Purified Water. Do not use if tamper-evident seal is broken or missing. Rx Only Net Contents: 16 fl oz (One Pint) 473 mL Principal Display Panel - 473 mL Bottle Label"],"package_label_principal_display_panel_table":["<table width=\"45%\"> <col width=\"80%\" align=\"left\" valign=\"top\"/> <col width=\"20%\" align=\"right\" valign=\"top\"/> <tbody> <tr styleCode=\"Toprule\"> <td>Dextromethorphan Hydrobromide, USP</td> <td>15 mg</td> </tr> <tr> <td>Chlorpheniramine Maleate, USP</td> <td>4 mg</td> </tr> <tr styleCode=\"Botrule\"> <td>Phenylephrine Hydrochloride, USP</td> <td>10 mg</td> </tr> </tbody> </table>"],"pediatric_use":["Pediatric Use Safety and effectiveness in the pediatric population, under 6, have not been established."],"precautions":["PRECAUTIONS Information for Patients Phenylephrine is banned and tested for by the U.S. Olympic Committee (USOC) and the National Collegiate Athletic Association (NCAA). Drug Interactions 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 are uncertain whether your prescription drug contains an MAOI, consult a health professional before taking this product. Pregnancy Category C Animal reproduction studies have not been conducted with this product. It is not known whether this medication can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Therefore, Trital™ DM should be given to a pregnant woman only if the potential benefit justifies the possible risk to the fetus. Pediatric Use Safety and effectiveness in the pediatric population, under 6, have not been established."],"pregnancy":["Pregnancy Category C Animal reproduction studies have not been conducted with this product. It is not known whether this medication can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Therefore, Trital™ DM should be given to a pregnant woman only if the potential benefit justifies the possible risk to the fetus."],"set_id":"b2d328e2-e543-45dd-892f-33022b033bed","spl_product_data_elements":["Trital DM Dextromethorphan Hydrobromide, Chlorpheniramine Maleate, and Phenylephrine Hydrochloride Dextromethorphan Hydrobromide Dextromethorphan Chlorpheniramine Maleate Chlorpheniramine Phenylephrine Hydrochloride Phenylephrine sodium benzoate citric acid monohydrate glycerin sorbitol water Clear"],"spl_unclassified_section":["Antihistamine/Nasal Decongestant/Cough Suppressant Alcohol Free • Sugar Free • Dye Free","Rx Only Manufactured by: Tri-Med Laboratories, Inc., Somerset, NJ 08873 Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487 REV. 6/09 ISS. 12/03"],"storage_and_handling":["Store at 25°C (77°F); excursions permitted to 15°-30° C (59°-86°F). See USP Controlled Room Temperature Protect from freezing. Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product."],"teratogenic_effects":["Category C Animal reproduction studies have not been conducted with this product. It is not known whether this medication can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Therefore, Trital™ DM should be given to a pregnant woman only if the potential benefit justifies the possible risk to the fetus."],"version":"1","warnings":["WARNINGS Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by a fever, consult a doctor. May cause drowsiness; alcohol; sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery. May cause excitability, especially in children. Do not take this product if you have heart disease, high blood pressure, thyroid disease, diabetes, a breathing problem such as emphysema or chronic bronchitis, glaucoma, or difficulty in urination due to enlargement of the prostate gland unless directed by doctor. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. A persistent cough may be a sign of a serious condition. If cough or other symptoms persist for more than one week, without improvement, tend to recur, or are accompanied by fever, rash, or persistent headache, consult a doctor. Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product. If pregnant, or planning to become pregnant or are currently breast-feeding please contact your physician, or health-care provider before using or continuing use."]}