Label: M-DRYL- diphenhydramine hydrochloride liquid

  • NDC Code(s): 58657-528-04, 58657-528-16
  • Packager: Method Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2023

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  • SPL UNCLASSIFIED SECTION

    M-Dryl

    Diphenhydramine Hydrochloride Oral Solution

    Antihistamine

    Cherry Flavor

    RELIEVES

    • Sneezing
    • Itchy, Watery Eyes
    • Runny Nose
    • Itchy Throat due to Allergies

    DO NOT USE IF TAMPER EVIDENT SEAL

    UNDER CAP IS BROKEN OR MISSING

    Alcohol Free

    Each 5 mL (1 teaspoonful) contains:

    Diphenhydramine HCl ................ 12.5 mg

    Drug Facts

  • Active ingredient

    (in each 5 mL = 1 tsp)

    Diphenhydramine HCl ..................................................... 12.5 mg

  • Purpose

  • Uses

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • sneezing
    • runny nose
    • itchy, watery eyes
    • itching of the nose or throat
  • Warnings

    Do not use

    • to make a child sleepy
    • with any other product containing diphenhydramine, even one used on skin

    Ask a doctor before use if you have

    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem such as emphysema or chronic bronchitis

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

    • marked drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    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. 

  • Directions

    • take every 4 to 6 hours
    • use an accurate measuring device to administer this Medication
    children under 2 years do not usedo not use
    children 2 to 5 yearsask a doctor
    children 6 years to under 12 years5 mL (1 tsp) to 10 mL (2 tsp); not more than 60 mL (12 tsp) in 24 hours
    adults and children 12 years and over 10 mL (2 tsp) to 20 mL (4 tsp); not more than 120 mL (24 tsp) in 24 hours
  • Other information

    • each tsp contains: sodium 5 mg
    • store at 15° to 30°C (59° to 86°F) 

    protect from freezing

  • Inactive ingredients

    Cherry Flavor, Citric Acid Anhydrous, FD&C red No. 40, Glycerin, Masking Agent, Propylene Glycol, Purified water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol Solution.

  • Questions?

    Serious side effects associated with use of this product may be reported to this number. Call 1-877-250-3427 Mon. - Fri. (8 a.m. to 5 p.m. CST).

  • PRINCIPAL DISPLAY PANEL

    NDC 58657-528-04

    M-Dryl

    Diphenhydramine Hydrochloride

    Oral Solution

    Antihistamine

    Cherry Flavor

    4 fl. oz. (120 mL)

    4oz

  • PRINCIPAL DISPLAY PANEL

    NDC 58657-528-16

    M-Dryl

    Diphenhydramine Hydrochloride

    Oral Solution

    Antihistamine

    Cherry Flavor

    16 fl. oz. (473 mL)

    16

  • INGREDIENTS AND APPEARANCE
    M-DRYL 
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58657-528
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58657-528-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2019
    2NDC:58657-528-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01208/01/2019
    Labeler - Method Pharmaceuticals, LLC (060216698)
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