M-dryl Liquid
FDA Label NDC 58657-528

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Method Pharmaceuticals, Llc for the product M-dryl (NDC 58657-528). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

(in each 5 mL = 1 tsp)

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

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 Panelndc 58657-528-04m-dryldiphenhydramine Hydrochloride Oral Solutionantihistaminecherry Flavor4 Fl. Oz. (120 mL) (M Dryl 01)

Principal Display Panelndc 58657-528-04m-dryldiphenhydramine Hydrochloride Oral Solutionantihistaminecherry Flavor4 Fl. Oz. (120 mL) (M Dryl 01)

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

Cherry Flavor
16 fl. oz. (473 mL)

Principal Display Panelndc 58657-528-16m-dryldiphenhydramine Hydrochloride Oral Solutionantihistaminecherry Flavor16 Fl. Oz. (473 mL) (M Dryl 02)

Principal Display Panelndc 58657-528-16m-dryldiphenhydramine Hydrochloride Oral Solutionantihistaminecherry Flavor16 Fl. Oz. (473 mL) (M Dryl 02)

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