SLEEP AID- diphenhydramine hcl capsule 
Strategic Sourcing Services 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

Principal Display Panel

COMPARE TO UNISOM® SLEEPGELS® ACTIVE INGREDIENT†

MAXIMUM STRENGTH

Sleep-Aid

Diphenhydramine HCl 50 mg

NIGHTTIME SLEEP-AID

For relief of occasional sleeplessness

Non habit-forming

SOFTGELS

ONE SOFTGEL PER DOSE

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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

Distributed by: Mckesson Corp.,

via Strategic Sourcing Services LLC.

Memphis TN 38141

www.fosterandthrive.com

 

Package Label

Diphenhydramine HCl 50 mg

FOSTER & THRIVE Maximum Strength Sleep-Aid

SLEEP AID 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-1151
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)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MANNITOL (UNII: 3OWL53L36A)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize13mm
FlavorImprint Code PC5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70677-1151-11 in 1 BOX03/31/2023
132 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01003/31/2023
Labeler - Strategic Sourcing Services LLC (116956644)

Revised: 5/2024
Document Id: 554e38e7-1a96-4d73-beec-8a8d1098f4d6
Set id: a512413c-639b-4846-b016-332a78b50ab7
Version: 2
Effective Time: 20240530
 
Strategic Sourcing Services LLC