Nytol QuickCaps

Dosage form: tablet, film coated
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: GlaxoSmithKline consumer Healthcare LP
NDC Code: 10158-043

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.

Drug Facts

Active ingredient (in each caplet)

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 before use if you have
a breathing problem such as emphysema or chronic bronchitis
glaucoma
trouble urinating due to 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 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 70mg
store below 25°C (77°F)

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

Principal Display Panel

NDC 10158-043-02

Nytol®

QuickCaps®

with Diphenhydramine HCl

NIGHTTIME SLEEP-AID

Easy to Swallow Caplets

Helps you fall asleep FAST!

16 CAPLETS

NYTOL  QUICKCAPS
diphenhydramine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10158-043
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 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
POLYETHYLENE GLYCOL 8000 
SILICON DIOXIDE 
STARCH, CORN 
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize14mm
FlavorImprint CodeN
Contains    
Packaging
#Item CodePackage Description
1NDC:10158-043-022 BLISTER PACK in 1 CARTON
18 TABLET, FILM COATED in 1 BLISTER PACK
2NDC:10158-043-044 BLISTER PACK in 1 CARTON
28 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33808/12/201109/30/2017
Labeler - GlaxoSmithKline consumer Healthcare LP (828924212)

Revised: 02/2013
 
GlaxoSmithKline consumer Healthcare LP

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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