Label: M-DRYL- diphenhydramine hydrochloride liquid

  • NDC Code(s): 58657-528-04, 58657-528-16
  • Packager: Method Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL

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 August 1, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • 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)

    PRINCIPAL DISPLAY PANEL
NDC 58657-528-04
M-Dryl
Diphenhydramine Hydrochloride 
Oral Solution
Antihistamine
Cherry Flavor
4 fl. oz. (120 mL)

  • PRINCIPAL DISPLAY PANEL

    NDC 58657-528-16
    M-Dryl
    Diphenhydramine Hydrochloride
    Oral Solution
    Antihistamine

    Cherry Flavor
    16 fl. oz. (473 mL)

    PRINCIPAL DISPLAY PANEL
NDC 58657-528-16
M-Dryl
Diphenhydramine Hydrochloride 
Oral Solution
Antihistamine
Cherry Flavor
16 fl. oz. (473 mL)

  • 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 FINALpart34108/01/2019
    Labeler - Method Pharmaceuticals, LLC (060216698)