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 Bryant Ranch Prepack. 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 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).


How Supplied



NDC: 63629-1160-1 473 mL in a BOTTLE


Package Label.Principal Display Panel



M-Dryl Oral Liquid 12.5 MG/5ML


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