FDA Label for M-dryl
View Indications, Usage & Precautions
M-dryl Product Label
The following document was submitted to the FDA by the labeler of this product Method Pharmaceuticals, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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 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).
Principal Display Panel
NDC 58657-528-04
M-Dryl
Diphenhydramine Hydrochloride
Oral Solution
Antihistamine
Cherry Flavor
4 fl. oz. (120 mL)
NDC 58657-528-16
M-Dryl
Diphenhydramine Hydrochloride
Oral Solution
Antihistamine
Cherry Flavor
16 fl. oz. (473 mL)
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