NYTOL- diphenhydramine hcl tablet 
Medtech Products Inc.

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.

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Nytol

Drug Facts

Active Ingredient

Diphenhydramine HCl, 25 mg

Purpose

Nighttime sleep-aid

Use

relieves occasional sleeplessness

Warnings

Do not use

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

Other information

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

Nytol QuickCaps 32 count carton

PRINCIPAL DISPLAY PANEL

Nytol QuickCaps with Diphenhydramine HCl

Nighttime Sleep-Aid

16 caplets

Nytol QuickCaps 16 count carton

NYTOL 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-211
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize14mm
FlavorImprint Code N
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-211-014 in 1 BOX06/01/2012
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:63029-211-022 in 1 BOX01/16/2013
28 in 1 BLISTER PACK; Type 0: Not a Combination Product
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
Document Id: 73997599-2800-4dea-96a2-7197d0b35506
Set id: c81d018a-0170-4396-81e9-2e13a53f868a
Version: 3
Effective Time: 20171217
 
Medtech Products Inc.