NIGHTTIME SLEEP-AID- diphenhydramine hydrochloride capsule, liquid filled 
NIGHTTIME SLEEP AID- diphenhydramine hydrochloride capsule, liquid filled 
Lil' Drug Store Products, Inc

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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Nighttime Sleep Aid

Drug Facts

Active ingredient (in each softgel)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

  • for the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep

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 beverages.

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

  • take only one dose (2 softgels) per day (24 hours)
  • swallow whole; do not crush, chew, or dissolve
  • adults & children 12 years and over: take 2 softgels at bedtime, if needed, or as directed by a doctor
  • children under 12 years of age: do not use

Other information

  • store between 20- 25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F) and high humidity
  • protect from light

Inactive ingredients

edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol 400, propylene glycol 1, purified water, sorbitan, sorbitol

1
may contain this ingredient

Questions or comments?

call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

Distributed by:
Lil' Drug Store Products, Inc.
9300 Earhart Lane SW
Cedar Rapids, IA 52404

PRINCIPAL DISPLAY PANEL - 12 Softgel Blister Pack Carton - NDC 66715-6843-0

QUALITY
⋆ GUARANTEED ⋆

Compare to the Active
Ingredients in ZZZQUIL® **

Nighttime
Sleep-Aid

Diphenhydramine HCl 25 mg
Sleep-Aid

  • Non-Habit Forming

ACTUAL SIZE

Not for treating cold or flu
See warnings

12
Softgels

Lil'
Drug Store ®

PRINCIPAL DISPLAY PANEL - 12 Softgel Blister Pack Carton - NDC 66715-6843-0

PRINCIPAL DISPLAY PANEL - 12 Softgel Blister Pack Carton - NDC 66715-6943-0

QUALITY
⋆ GUARANTEED ⋆

Compare to the Active
Ingredients in ZZZQUIL® **

Nighttime
Sleep-Aid

Diphenhydramine HCl 25 mg
Sleep-Aid

  • Non-Habit Forming

ACTUAL SIZE

Not for treating cold or flu
See warnings

12
Softgels

Lil'
Drug Store ®

PRINCIPAL DISPLAY PANEL - 12 Softgel Blister Pack Carton - NDC 66715-6943-0
NIGHTTIME SLEEP-AID 
diphenhydramine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6843
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorpurpleScoreno score
ShapeOVALSize13mm
FlavorImprint Code A41
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66715-6843-012 in 1 CARTON02/15/201911/18/2023
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33809/05/201411/18/2023
NIGHTTIME SLEEP AID 
diphenhydramine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6943
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorpurpleScoreno score
ShapeOVALSize13mm
FlavorImprint Code 602
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66715-6943-012 in 1 CARTON02/15/201911/18/2023
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33802/15/201911/18/2023
Labeler - Lil' Drug Store Products, Inc (093103646)

Revised: 12/2020
Document Id: b685df1d-808c-44cf-e053-2995a90a38cd
Set id: f840ced4-ab4f-4873-abe8-568f01798906
Version: 6
Effective Time: 20201215
 
Lil' Drug Store Products, Inc