M-HIST PD (TRIPROLIDINE HYDROCHLORIDE) LIQUID [METHOD PHARMACEUTICALS, LLC]

M-HIST PD (TRIPROLIDINE HYDROCHLORIDE) LIQUID [METHOD PHARMACEUTICALS, LLC]
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NDC 58657-535-30
Set ID 9e03e4b8-eea0-4afb-ab63-ff36c858b814
Category HUMAN OTC DRUG LABEL
Packager Method Pharmaceuticals, LLC
Generic Name
Product Class
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    58657-535-30
    M-Hist PD
    Liquid

    Drug Facts

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  • Active ingredient (in each mL)

    Triprolidine HCl 0.625 mg

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  • Purpose

    Antihistamine

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  • Uses

    • temporarily relieves: ■runny nose
    • sneezing ■itching of nose and throat
    • itchy, watery eyes due to hay fever or other upper respiratory allergies or allergic rhinitis
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  • Warnings

    • May cause excitability, especially in children

    Do Not Use

    • if you or your children are taking sedatives or tranquilizers, without first consulting your doctor
    • with any other product containing triprolidine

    Ask a doctor before use if your child has

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • difficulty in urination due to enlargement of the prostate gland

    When using this product

    • do not use more than directed
    • may cause drowsiness
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if:

    • nervousness, dizziness or sleeplessness occurs
    • symptoms do not improve within 7 days or are accompanied by a fever

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

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  • Directions

    • take every 6 hours
    • do not take more than 4 doses in 24 hours or as directed by a doctor
    • do not give more than directed or exceed the recommended daily dosage
    • use only with enclosed dropper
    • do not use enclosed dropper for any other drug product

    Adults and children 12 years of age and over       4 mL (2.5 mg)
    Children 6 to under 12 years of age             2 mL (1.25 mg)
    Children under 6 years of age                   ask a doctor

    • store at controlled room temperature 15°-30°C (59°-86°F)
    • Tamper Evident: Do not use if seal is broken or missing.
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  • Inactive ingredients

    Banana flavor, citric acid anhydrous, FD&C Red #40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol, strawberry flavor, sucralose.

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  • Questions?

    Call 1-877-250-3427

    Distributed by:
    Method Pharmaceuticals, LLC
    Fort Worth, TX 76118

    Professional Labeling

    Take under guidance of Health Professionals.

    Children 4 months to under 2 years of age      0.5 mL (0.313 mg)
    Children 2 to under 4 years of age      1 mL (0.626 mg)
    Children 4 to under 6 years of age      1.5 mL (0.938 mg)

    Take every 6 hours.

    Do not exceed 4 doses in 24 hours.

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  • PRINCIPAL DISPLAY PANEL

    58657-535-30
    M- Hist PD
    Liquid
    1 mL
    1 oz. (30 mL)

    PRINCIPAL DISPLAY PANEL
58657-535-30
M- Hist PD
Liquid
1 mL
1 oz. (30 mL)

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  • INGREDIENTS AND APPEARANCE
    M-HIST PD 
    triprolidine hydrochloride liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:58657-535
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE 0.625 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color RED Score     
    Shape Size
    Flavor BANANA, STRAWBERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58657-535-30 1 in 1 CARTON 11/08/2016
    1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 11/08/2016
    Labeler - Method Pharmaceuticals, LLC (060216698)
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