{"active_ingredient":["Drug Facts Active Ingredients (in each tablet) Guaifenesin 388 mg Dextromethorphan HBr 28 mg Phenylephrine HCl 10 mg"],"ask_doctor":["Ask a doctor before use if you have heart disease excessive phlegm (mucus) high blood pressure diabetes thyroid disease difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema"],"do_not_use":["Do not use this product more than the recommended dosage, or 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, ask a health professional."],"dosage_and_administration":["Directions Do not exceed recommended doses in a 24 hour period • Adults and Children 12 years and over: 1 tablet every 6 to 8 hours. Do not exceed 4 tablets in 24 hours. • Children 6 to 12 years: 1/2 tablet every 6 to 8 hours. Do not exceed 2 tablets in 24 hours. • Children under 6 years of age: ask a doctor"],"effective_time":"20250626","id":"387cb3bb-97f4-b2ab-e063-6294a90a2d8d","inactive_ingredient":["Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Silicate, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Mineral Oil, Polyvinylpyrrolidone, Silica, Sodium Lauryl Sulfate, Stearic Acid, Titanium Dioxide and Triacetin."],"indications_and_usage":["Uses temporarily relieves these symptoms associated with a cough, the common cold, hay fever, or other upper respiratory allergies helps loosen phlegm (mucus) loosens nasal congestion thin bronchial secretions drain bronchial tubes make coughs more productive clears stuffy nose clear nasal passageways shrinks swollen membranes"],"keep_out_of_reach_of_children":["Keep out of the reach of children."],"openfda":{},"overdosage":["In case of accidental overdose, get medical help or contact a Poison Control Center immediately."],"package_label_principal_display_panel":["Giltuss TR NDC 58552-317-02 GILTUSS ® TOTAL RELEASE EXPECTORANT, ANTITUSSIVE, AND NASAL DECONGESTANT SUGAR FREE AND PRESERVATIVE FREE Each scored tablet contains: Guaifenesin................................388 mg. Dextromethorphan HBr................28 mg. Phenylephrine HCl........................10 mg. 100 Tablets MANUFACTURED FOR: GIL PHARMACEUTICAL CORP. PONCE, PUERTO RICO 00716 4060-24BB-1 4060-24BB-2","Exactuss TR NDC: 58552-327-01 Exactuss Total Release Expectorant, Antitissive, and Nasal Decongestant Sugar Free and Preservative free Exactuss TR is the bioequivalent and contains the exact ingredients of Giltuss TR 100 Tablets Manufactured For Gil Pharmaceutical Corp. Ponce, Puerto Rico 00716 4060-100G Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Expectorant Antitussive Nasal Decongestant"],"questions":["Questions? Call 787-848-9114"],"set_id":"a854de22-2f90-48c9-8cde-98446f7958b9","spl_product_data_elements":["GILTUSS TOTAL RELEASE Guaifenesin, Dextromethorphan HBr, and Phenylephrine HCl CROSCARMELLOSE SODIUM CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE HYPROMELLOSES TALC MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE LIGHT MINERAL OIL POVIDONE K30 SILICON DIOXIDE SODIUM LAURYL SULFATE STEARIC ACID TITANIUM DIOXIDE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE TRIACETIN GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GIL;GIL;303;303 EXACTUSS TOTAL RELEASE Guaifenesin, Dextromethorphan HBr, and Phenylephrine HCl CROSCARMELLOSE SODIUM CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE HYPROMELLOSES TALC MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE LIGHT MINERAL OIL POVIDONE K30 SILICON DIOXIDE SODIUM LAURYL SULFATE STEARIC ACID TITANIUM DIOXIDE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE TRIACETIN GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GIL;GIL;303;303"],"spl_unclassified_section":["Other Information store at room temperature, USP do not use if imprinted safety seal under cap is broken or missing.","Manufactured for: GIL PHARMACEUTICAL CORP. Ponce, Puerto Rico 00717-1565"],"stop_use":["Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs symptoms are accompanied by fever, rash, persistent headache, or excessive phlegm (mucus) cough and congestion do not improve within 7 days or tend to recur These could be signs of a serious condition."],"version":"6","warnings":["Do not use this product more than the recommended dosage, or 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, ask a health professional. Ask a doctor before use if you have heart disease excessive phlegm (mucus) high blood pressure diabetes thyroid disease difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs symptoms are accompanied by fever, rash, persistent headache, or excessive phlegm (mucus) cough and congestion do not improve within 7 days or tend to recur These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately."]}