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

Drug Label Information

Updated July 9, 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
    OTC Monograph DrugM01205/22/2023
    Labeler - Poly Pharmaceuticals, Inc. (198449894)
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