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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

(in each caplet)

Diphenhydramine HCI 25 mg

Purpose

Nighttime sleep-aid

Use

relieves occasional sleeplessness

Warnings

Do not use
  • in children over 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • with other antihistamines

Ask a doctor before use if you have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product
  • avoid alcoholic beverages
  • be careful when driving a motor 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, get medical help or contact a Poison Control Center right away.

Directions
  • adults and children 12 years of age and over: take 2 caplets at bedtime if needed, or as directed by a doctor

Other information
  • each caplet contains: calcium 70 mg
  • store below 25ºC (77ºF)

Inactive ingredients

carnauba wax, dibasic calcium phosphate, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, starch

Questions or comments?

1-866-255-5203 (English/Spanish) weekdays

TAMPER EVIDENT FEATURE:

This product is protected in a sealed blister. Do not use if blister or printed foil is broken or torn.




PRINCIPAL DISPLAY PANEL

Nytol® QUICKCAPS®
with Diphenhydramine HCl
NIGHTTIME SLEEP-AID
THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN
32 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
CARNAUBA WAX 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
SILICON DIOXIDE 
STARCH, CORN 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize14mm
FlavorImprint Code N
Contains    
Packaging
#Item CodePackage Description
1NDC:63029-211-014 BLISTER PACK (4 BLISTER) in 1 BOX
18 TABLET (8 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: 06/2012
Document Id: 525dcf76-210b-468e-b766-3a9c8d690706
Set id: c81d018a-0170-4396-81e9-2e13a53f868a
Version: 2
Effective Time: 20120614
 
Medtech Products Inc.

See also...

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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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