FDA Label for Nytol

View Indications, Usage & Precautions

Nytol Product Label

The following document was submitted to the FDA by the labeler of this product Medtech Products Inc.. 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



Diphenhydramine HCl, 25 mg


Purpose



Nighttime sleep-aid


Use



relieves occasional sleeplessness


Warnings



Do not use

  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • with other antihistamines

Ask A Doctor Or Pharmacist Before Use If You Are



taking sedatives or tranquilizers


Ask A Doctor Before Use If You Have



  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • glaucoma

When Using This Product



  • avoid alcoholic beverages
  • be careful when driving a moter vehicle or operating machinery

Stop Use And Ask A Doctor If



sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.


If Pregnant Or Breast-Feeding,



ask a health care professional before use.


Keep Out Of Reach Of Children.



In case of overdose, gret medical help or contact a Poison Control center (1-800-222-1222) right away.


Directions



  • adults and children 12 years of age and over: take 2 caplets (50 mg) at bedtime if needed, or as directed by a doctor
  • children under 12 years: do not use

Other Information



  • each caplot contains: calcium 12 mg
  • store at 20°-25°C (68°-77°F)

Inactive Ingredients



crosscarmellose sodium, dicalcium phosphate, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, mineral oil, silica, stearic acid, talc, titanium dioxide, tracetin


Principal Display Panel



Nytol QuickCaps with Diphenhydramine HCl

Nighttime Sleep-Aid

32 caplets


Principal Display Panel



Nytol QuickCaps with Diphenhydramine HCl

Nighttime Sleep-Aid

16 caplets


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