NIGHTTIME SLEEP AID- diphenhydramine hcl capsule 
P & L Development, LLC

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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 a 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 (1-800-222-1222) right away.

Directions

Other information

Inactive ingredients

FD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, purified water, sorbitol sorbitan, white ink


Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

†Compare to the active ingredient in Unisom® SleepGels®

Sleep Aid

Diphenhydramine HCl, 50 mg

Nighttime Sleep-Aid

non-habit-forming

softgels

One Softgel Per Dose

†This product is not manufactured or distributed by Chattem, Inc., distributor of Unisom® SleepGels®.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

Package Label

Diphenhydramine HCl 50 mg

READYinCASE Sleep Aid

NIGHTTIME SLEEP AID 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-916
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)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
MANNITOL (UNII: 3OWL53L36A)  
Product Characteristics
ColorblueScoreno score
ShapeCAPSULESize13mm
FlavorImprint Code PC5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59726-916-641 in 1 BOX03/26/2021
164 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:59726-916-321 in 1 BOX03/26/2021
232 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01003/26/2021
Labeler - P & L Development, LLC (800014821)

Revised: 4/2024
Document Id: 8894f9fa-aa99-4730-be04-b1acdefa89f0
Set id: 59c063ad-6ea3-4f1d-a20e-5e5e062a9098
Version: 4
Effective Time: 20240430
 
P & L Development, LLC