HISTEX-DM New Formulation
DEXTROMETHORPHAN HBr, PSEUDOEPHEDRINE HCI, and TRIPROLIDINE HCI · Syrup · Oral
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
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
Uses
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
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.
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.
Ask a doctor before use
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
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
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.
Pregnancy or breast-feeding
If pregnant or breast-feeding, ask a health professional before use.
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.
Directions
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
Other information
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.
Inactive ingredients
Inactive ingredients Citric Acid, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Bensoate, Soduim Citrate, Sodium Saccharin, Sorbitol Solution.
Questions?
Questions? Comments? Call 1-866-633-9033. Manufactured for: Allegis Pharmaceuticals, Inc. Canton MS 39046 www.allegispharma.com Rev. 01/2025
Label text from the FDA structured product label by Allegis Pharmaceuticals, LLC (revised Mar 10, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Dextromethorphan Hydrobromide in 1 product
- Pseudoephedrine Hydrochloride in 1 product
- Triprolidine Hydrochloride in 1 product
HISTEX-DM New Formulation NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 28595-310 | Dextromethorphan Hydrobromide 20 mg/5mL; Pseudoephedrine Hydrochloride 30 mg/5mL; Triprolidine Hydrochloride 2.5 mg/5mL Syrup | Allegis Pharmaceuticals, LLC | OTC MONOGRAPH DRUG |
Frequently asked questions
What is HISTEX-DM New Formulation used for?
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
Who makes HISTEX-DM New Formulation?
HISTEX-DM New Formulation is listed by 1 labeler in the FDA NDC directory, including Allegis Pharmaceuticals, LLC.