SLEEP AID MAXIMUM STRENGTH- 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

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 right away (1-800-222-1222)

Directions

Other information

Inactive ingredients

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

Questions or comments?

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

Principal Display Panel

Maximum Strength

Sleep-Aid

diphenhydramine HCl 50 mg

nighttime sleep-aid

safe, non-habit forming

softgels

One Softgel Per Dose

†Compare to the active ingredient in Unisom® SleepGels®

†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.

Distributed by: PL Developments

200 Hicks Street

Westbury, NY 11590

Package Label

Diphenhydramine HCl 50 mg

WELLNESS BASICS Maximum Strength Sleep Aid

SLEEP AID  MAXIMUM STRENGTH
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-816
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:59726-816-9296 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/29/2019
2NDC:59726-816-641 in 1 BOX11/29/2019
264 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:59726-816-292 in 1 BOX11/29/2019
396 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01211/29/2019
Labeler - P & L Development, LLC (800014821)

Revised: 10/2023
Document Id: 56c200ee-5dd0-45bf-a1e8-5ff306616dc5
Set id: 17639c3b-5d36-41f5-bd0d-da29075abd09
Version: 4
Effective Time: 20231023
 
P & L Development, LLC