Active Ingredient
(in each 5 mL = 1 tsp)
Diphenhydramine HCl ..................................................... 12.5 mg
M-dryl Liquid
FDA Label NDC 72162-1674
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bryant Ranch Prepack for the product M-dryl (NDC 72162-1674). 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
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 use | do not use |
| children 2 to 5 years | ask a doctor |
| children 6 years to under 12 years | 5 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).
How Supplied
M-Dryl
Diphenhydramine Hydrochloride Oral Solution
NDC: 72162-1674-4: 473 mL in a BOTTLE
NDC: 72162-1674-2: 120 mL in a BOTTLE
Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504
Package Label.Principal Display Panel
M-Dryl Oral Liquid 12.5 MG/5ML
Label (Lbl721621674)
* Please review the disclaimer below.
