GOOD SENSE NIGHTTIME SLEEP AID- diphenhydramine hydrochloride tablet 
L Perrigo Company

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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Perrigo Nighttime Sleep Aid Drug Facts

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

for relief of occasional sleeplessness

Warnings

Do not use

•
in children under 12 years of age
•
with any other product containing diphenhydramine, even one used on skin

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

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

avoid alcoholic drinks

Stop use and ask a doctor if

sleeplessness lasts 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 and over

take 2 caplets at bedtime if needed, or as directed by a doctor

children under 12 years

do not use

Other information

•
store at 20º-25ºC (68º-77ºF)

Inactive ingredients

colloidal silicon dioxide, crospovidone, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Fall Asleep Fast!

Nighttime Sleep Aid

Diphenhydramine HCl

Contains no Pain Reliever

For a Restful Night’s Sleep

Non habit-forming

Rapid Release

Nighttime Sleep Aid Carton

Nighttime Sleep Aid Carton

Nighttime Sleep Aid Carton

GOOD SENSE NIGHTTIME SLEEP AID 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-0151
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
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize16mm
FlavorImprint Code L151
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0113-0151-781 in 1 CARTON09/02/200901/01/2014
1100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33809/02/200901/01/2014
Labeler - L Perrigo Company (006013346)

Revised: 11/2017
Document Id: 233cf683-5bbe-465f-aa81-6235b3dc435c
Set id: b9e0fcda-c530-4970-a8c8-722748a35f67
Version: 2
Effective Time: 20171102
 
L Perrigo Company