GOOD SENSE SLEEP AID- diphenhydramine hydrochloride capsule, liquid filled 
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 Sleep Aid Softgels Drug Facts

Active ingredient (in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Use

for relief of occasional sleeplessness

Warnings

Do not use

for 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
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 drinks

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 (1-800-222-1222).

Directions

adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

Other information

store at 20-25°C (68-77°F)

Inactive ingredients

edible ink*, FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

Questions or comments?

1-800-719-9260

Principal Display Panel

Non-Habit Forming

One Softgel Per Dose

Sleep Aid Softgels

Diphenhydramine HCl Softgels, 50 mg

Nighttime Sleep-Aid

Actual Size

Compare to active ingredient of Unisom® SleepGels®

100% SATISFACTION GUARANTEED

32 Softgels

sleep aid softgels image
GOOD SENSE SLEEP AID 
diphenhydramine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-1909
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorBLUE (clear to light blue) Scoreno score
ShapeOVALSize13mm
FlavorImprint Code 5V6
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0113-1909-641 in 1 CARTON05/30/2019
132 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33805/30/2019
Labeler - L. Perrigo Company (006013346)

Revised: 6/2019
Document Id: 97d65237-0aa3-4a53-9b0b-d5fb5533f69b
Set id: 97d65237-0aa3-4a53-9b0b-d5fb5533f69b
Version: 1
Effective Time: 20190603
 
L. Perrigo Company