M-DRYL- diphenhydramine hydrochloride liquid 
Method Pharmaceuticals, LLC

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.

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M-Dryl

M-Dryl

Diphenhydramine Hydrochloride Oral Solution

Antihistamine

Cherry Flavor

RELIEVES

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

Warnings

Do not use

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

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

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)

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)

Revised: 8/2019
Document Id: 3bbf9ece-5044-48b6-bee4-4731ab16a66e
Set id: 5a60c923-8bb7-427f-9636-08ed5474f71b
Version: 1
Effective Time: 20190801
 
Method Pharmaceuticals, LLC