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Drug Facts
Histex-dm New Formulation Syrup
FDA Label NDC 28595-310
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegis Pharmaceuticals, Llc for the product Histex-dm New Formulation (NDC 28595-310). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, do not use this product, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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
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
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - 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
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
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
Citric Acid, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Bensoate, Soduim Citrate, Sodium Saccharin, Sorbitol Solution.
Questions? Comments?
Call 1-866-633-9033.
Manufactured for: Allegis Pharmaceuticals, Inc.
Canton MS 39046
www.allegispharma.com
Rev. 01/2025
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)
* Please review the disclaimer below.
