SLEEPAID SOFTGELS- diphenhydramine hydrochloride capsule, liquid filled 
PIONEER LIFE SCIENCES, LLC

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SleepAid Softgels Diphenhydramine HCl 50 mg

Active Ingredient (In Each Softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses

for relief of occasional sleeplessness

Do not use:

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

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 between 15-30°C (59-86°F). Avoid high humidity. Protect from light.

Inactive Ingredients:

Polyethylene Glycol, Gelatin, Sorbitol, Sorbitan Anhydrous, Glycerin, Brilliant Blue FCF.

Questions Or Comments?

Call toll-free 1 (732) 689-5070 Monday through Friday 9 am to 5 pm EST.

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepGels®

Distributed by: Gencare Consumer Products, LLC
40E Cotters Ln, Suite A, East Brunswick, NJ 08816

NDC 72090-023-02 (96 Sofgels t in HDPE Bottle)

PL0166-SleepAid SoftGels Diphenhydramine HCL 50mg-96cts-02.05.24 Signed_page-0001

SLEEPAID SOFTGELS 
diphenhydramine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72090-023
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
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
GELATIN (UNII: 2G86QN327L)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
GLYCERIN (UNII: PDC6A3C0OX)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize15mm
FlavorImprint Code cp71
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72090-023-0296 in 1 BOTTLE; Type 0: Not a Combination Product04/25/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01004/25/2024
Labeler - PIONEER LIFE SCIENCES, LLC (014092742)

Revised: 4/2024
Document Id: 59ca8da7-91d7-4c9f-b2ba-2ddce95ff16b
Set id: c1dab616-c3ff-4d0a-be13-e8dc6b1a26cc
Version: 1
Effective Time: 20240424
 
PIONEER LIFE SCIENCES, LLC