Label: HISTEX-DM- dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine hydrochloride syrup

  • NDC Code(s): 28595-804-16
  • Packager: Allegis Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 8, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each 5 mL teaspoonful)Purpose
    Dextromethorphan HBr 20 mgCough Suppressant
    Phenylephrine HCl 10 mgDecongestant
    Triprolidine HCl 2.5 mgAntihistamine
  • 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. These could be signs of a serious condition.
    • new symptoms occur

    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.

  • Directions

    Do not exceed recommended dosage.

    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
  • 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.

    Dispense in a tight, light-resistant container with a child-resistant cap.

  • Inactive ingredients

    Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Grape Flavor.

  • Questions? Comments?

    Call 1-866-633-9033.

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    NDC 28595-804-16

    Antihistamine • Decongestant

    Cough Suppressant

    HISTEX™-DM

    Syrup

    Each teaspoonful (5 mL)

    contains:

    Dextromethorphan HBr 20 mg

    Phenylephrine HCl 10 mg

    Triprolidine HCl 2.5 mg

    Sugar-Free • Dye Free

    Alcohol Free

    Grape Flavor

    16 fl oz (473 mL)

    Label

  • INGREDIENTS AND APPEARANCE
    HISTEX-DM 
    dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine hydrochloride syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:28595-804
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
    TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:28595-804-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/19/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/19/2014
    Labeler - Allegis Pharmaceuticals, LLC (792272861)
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