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
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 20, 2022

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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 finalpart34103/19/2014
    Labeler - Allegis Pharmaceuticals, LLC (792272861)
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