{"active_ingredient":["Active ingredients (in each 5 mL teaspoonful) Purpose Dextromethorphan HBr 20 mg Cough Suppressant Pseudoephedrine HCI 30 mg Nasal Decongestant Triprolidine HCl 2.5 mg Antihistamine"],"active_ingredient_table":["
Active ingredients (in each 5 mL teaspoonful)Purpose
Dextromethorphan HBr 20 mgCough Suppressant
Pseudoephedrine HCI 30 mgNasal Decongestant
Triprolidine HCl 2.5 mgAntihistamine
"],"ask_doctor":["Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis heart disease high blood pressure thyroid disease diabetes glaucoma a persistent or chronic cough such occurs with smoking, asthma, chronic bronchitits, or emphysema a cough that occurs with too much phlegm (mucus) trouble urinating due to an enlarged prostate gland Ask a doctor before use if you are taking sedatives or tranquilizers"],"do_not_use":["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 giving this product."],"dosage_and_administration":["Directions Do not exceed recommended dosage. AGE DOSE Adults and Children 12 years of age and older: 1 teaspoonful (5 mL) every 4 hours, not to exceed 4 teaspoonfuls (20 mL) in 24 hours, or as directed by a doctor Children 6 to under 12 years of age ½ teaspoonful (2.5 mL) every 4 hours, not to exceed 2 teaspoonfuls (10 mL) in 24 hours, or as directed by a doctor. Children under 6 years of age Consult a doctor"],"dosage_and_administration_table":["
AGEDOSE
Adults and Children 12 years of age and older:1 teaspoonful (5 mL) every 4 hours, not to exceed 4 teaspoonfuls (20 mL) in 24 hours, or as directed by a doctor
Children 6 to under 12 years of age½ teaspoonful (2.5 mL) every 4 hours, not to exceed 2 teaspoonfuls (10 mL) in 24 hours, or as directed by a doctor.
Children under 6 years of ageConsult a doctor
"],"effective_time":"20250310","id":"3001043a-7932-0867-e063-6294a90a91e6","inactive_ingredient":["Inactive ingredients Citric Acid, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Bensoate, Soduim Citrate, Sodium Saccharin, Sorbitol Solution."],"indications_and_usage":["Uses temporarily relieves these symptoms due to common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: cough due to minor throat or bronchial irritation runny nose sneezing itching of the nose or throat itchy, watery eyes nasal congestion reduces swelling of nasal passages"],"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":{"application_number":["M012"],"brand_name":["HISTEX-DM New Formulation"],"generic_name":["DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCI, AND TRIPROLIDINE HCI"],"is_original_packager":[true],"manufacturer_name":["Allegis Pharmaceuticals, LLC"],"package_ndc":["28595-310-16"],"product_ndc":["28595-310"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["2707699"],"spl_id":["3001043a-7932-0867-e063-6294a90a91e6"],"spl_set_id":["30010401-e5b4-2bd9-e063-6394a90a0b0b"],"substance_name":["DEXTROMETHORPHAN HYDROBROMIDE","PSEUDOEPHEDRINE HYDROCHLORIDE","TRIPROLIDINE HYDROCHLORIDE"],"unii":["9D2RTI9KYH","6V9V2RYJ8N","YAN7R5L890"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label NDC 28595-310-16 Antihistamine - Nasal Decongestant - Cough Suppressant HISTEX™-DM New Formulation Syrup Each teaspoonful (5 mL) contains: Dextromethorphan HBr 20 mg Pseudoephedrine HCI 30mg Triprolidine HCl 2.5 mg Sugar-Free - Dye Free - Alcohol Free Grape Flavor 16 fl oz (473 mL) Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Active ingredients (in each 5 mL teaspoonful) Purpose Dextromethorphan HBr 20 mg Cough Suppressant Pseudoephedrine HCI 30 mg Nasal Decongestant Triprolidine HCl 2.5 mg Antihistamine"],"purpose_table":["
Active ingredients (in each 5 mL teaspoonful)Purpose
Dextromethorphan HBr 20 mgCough Suppressant
Pseudoephedrine HCI 30 mgNasal Decongestant
Triprolidine HCl 2.5 mgAntihistamine
"],"questions":["Questions? Comments? Call 1-866-633-9033. Manufactured for: Allegis Pharmaceuticals, Inc. Canton MS 39046 www.allegispharma.com Rev. 01/2025"],"set_id":"30010401-e5b4-2bd9-e063-6394a90a0b0b","spl_product_data_elements":["HISTEX-DM New Formulation DEXTROMETHORPHAN HBr, PSEUDOEPHEDRINE HCI, and TRIPROLIDINE HCI CITRIC ACID MONOHYDRATE GLYCERIN PROPYLENE GLYCOL WATER SODIUM CITRATE, UNSPECIFIED FORM SACCHARIN SODIUM SORBITOL DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE TRIPROLIDINE HYDROCHLORIDE TRIPROLIDINE SODIUM BENZOATE GRAPE"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur or is accompanied by a fever, rash or persistent headache. new symptoms occur These could be signs of a serious condition."],"storage_and_handling":["Other Information Store at 15°-30° C (59°-86° F). Tamper evident by foil seal under cap. Do not use if foil seal is missing or broken."],"version":"1","warnings":["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 giving this product. Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis heart disease high blood pressure thyroid disease diabetes glaucoma a persistent or chronic cough such occurs with smoking, asthma, chronic bronchitits, or emphysema a cough that occurs with too much phlegm (mucus) trouble urinating due to an enlarged prostate gland Ask a doctor before use if you are taking sedatives or tranquilizers When using this product excitability may occur, especially in children may cause drowsiness alcohol, sedatives and tranquilizers may increase the drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur or is accompanied by a fever, rash or persistent headache. 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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product excitability may occur, especially in children may cause drowsiness alcohol, sedatives and tranquilizers may increase the drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery"]}