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Nytol

Dosage form: tablet
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Medtech Products Inc.
NDC Code: 63029-211

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Nytol

Drug Facts

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

NYTOL 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-211
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
HYPROMELLOSE, UNSPECIFIED 
LACTOSE, UNSPECIFIED FORM 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
MINERAL OIL 
SILICON DIOXIDE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
TRIACETIN 
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize14mm
FlavorImprint CodeN
Contains    
Packaging
#Item CodePackage Description
1NDC:63029-211-014 BLISTER PACK in 1 BOX
18 TABLET in 1 BLISTER PACK
2NDC:63029-211-022 BLISTER PACK in 1 BOX
28 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33806/01/2012
Labeler - Medtech Products Inc. (122715688)

Revised: 12/2017
 
Medtech Products Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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