Label: ENDAL- triprolidine hcl, dextromethorphan hbr liquid

  • NDC Code(s): 50991-136-15, 50991-136-16
  • Packager: Poly Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated January 27, 2024

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  • Active Ingredient

    Triprolidine HCl, Dextromethorphan HBr

  • Purpose

    Antihistimine, Antitussive

  • Uses

    Uses temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes
    • cough due to minor throat and bronchial irritation
  • 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 taking this product.

    Ask a doctor before use if you have

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • difficulty in urination due to the enlargement of the prostate gland
    • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
    • a cough that occurs with too much phlegm
    • a chronic pulmonary disease or shortness of breath, or children who are taking other drugs
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes

    Ask a doctor or pharmacist before use

    if you are taking sedatives or tranquilizers.

    When using this product

    • excitability may occur, especially in children
    • may cause marked drowsiness
    • avoid alcoholic drinks
    • may cause or aggravate constipation
    • alcohol, sedatives, and tranquilizers may increase drowsiness effect

    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

    • 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

    AGEDOSE
    Adults and children over 12 years of age2 teaspoonfuls (10 mL) every 4 to 6 hours,
    over 12 years not to exceed 8 teaspoonfuls in
    of age: 24 hours, or as directed by a doctor.
    Children 6 to under 12 years of age1 teaspoonful (5 mL) every 4 to 6 hours,
    12 years of age: not to exceed 4 teaspoonfuls in
    24 hours, or as directed by a doctor.
    Children under 6 years of ageConsult a doctor.

  • Other Information

    Store at 59° - 86°F (15° - 30°C)

  • Inactive Ingredients

    Citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin, sorbitol solution.

  • Questions? Comments?

    Serious side effects associated with use of this product may be reported to this number. Call 1-800-882-1041 Mon - Fri (8 a.m. to 5 p.m. CST)

  • Package Label

    label

  • INGREDIENTS AND APPEARANCE
    ENDAL 
    triprolidine hcl, dextromethorphan hbr liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50991-136
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE1.25 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50991-136-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product05/22/2023
    2NDC:50991-136-1515 mL in 1 BOTTLE; Type 0: Not a Combination Product05/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/22/2023
    Labeler - Poly Pharmaceuticals, Inc. (198449894)
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