NYTOL QUICKCAPS- diphenhydramine hcl tablet, film coated 
GlaxoSmithKline consumer Healthcare LP

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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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 Quick Caps 16 count carton
NYTOL  QUICKCAPS
diphenhydramine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10158-043
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
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize14mm
FlavorImprint Code N
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10158-043-022 in 1 CARTON
18 in 1 BLISTER PACK
2NDC:10158-043-044 in 1 CARTON
28 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: 2/2013
Document Id: ed79e31b-8e07-48ec-8eab-b0260e930bad
Set id: 74ec5b09-def5-4d19-97d5-425f4465731d
Version: 3
Effective Time: 20130219
 
GlaxoSmithKline consumer Healthcare LP