Drugplain

HISTEX-DM New Formulation 20 mg/5mL

DEXTROMETHORPHAN HBr, PSEUDOEPHEDRINE HCI, and TRIPROLIDINE HCI · SYRUP · Allegis Pharmaceuticals, LLC

No Recall History
Plain English

HISTEX-DM New Formulation is a syrup containing dextromethorphan hbr, pseudoephedrine hci, and triprolidine hci at 20 mg/5mL, taken oral. Manufactured by Allegis Pharmaceuticals, LLC.

Key Facts

Brand Name
HISTEX-DM New Formulation
Generic Name
DEXTROMETHORPHAN HBr, PSEUDOEPHEDRINE HCI, and TRIPROLIDINE HCI
NDC Code (Product)
28595-310
Manufacturer
Allegis Pharmaceuticals, LLC
Strength
20 mg/5mL
Dosage Form
SYRUP
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
03/10/2025

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & 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

Dosage & 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

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 mor

Frequently Asked Questions

What is HISTEX-DM New Formulation used for?

HISTEX-DM New Formulation contains DEXTROMETHORPHAN HBr, PSEUDOEPHEDRINE HCI, and TRIPROLIDINE HCI. It is a syrup taken oral. Consult your doctor for specific uses.

Is HISTEX-DM New Formulation a controlled substance?

HISTEX-DM New Formulation is not classified as a controlled substance by the DEA.

What is the generic name for HISTEX-DM New Formulation?

The generic name for HISTEX-DM New Formulation is DEXTROMETHORPHAN HBr, PSEUDOEPHEDRINE HCI, and TRIPROLIDINE HCI. There are no other listed brand versions of DEXTROMETHORPHAN HBr, PSEUDOEPHEDRINE HCI, and TRIPROLIDINE HCI.

What is the NDC code for HISTEX-DM New Formulation 20 mg/5mL?

The NDC (National Drug Code) for HISTEX-DM New Formulation 20 mg/5mL is 28595-310, listed by Allegis Pharmaceuticals, LLC.

Product NDC

28595-310

Package NDC

28595-310-16

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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