NIGHTTIME SLEEP-AID- diphenhydramine hydrochloride capsule, liquid filled NIGHTTIME SLEEP AID- diphenhydramine hydrochloride capsule, liquid filled

Nighttime Sleep Aid by

Drug Labeling and Warnings

Nighttime Sleep Aid by is a Otc medication manufactured, distributed, or labeled by Lil' Drug Store Products, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 glycol1, 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)

SPL UNCLASSIFIED SECTION

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:

66715-6943-0

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®

INGREDIENTS AND APPEARANCE

NIGHTTIME SLEEP-AID 
diphenhydramine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66715-6843
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M)	Diphenhydramine Hydrochloride	25 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	PURPLE	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	A41
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66715-6843-0	12 in 1 CARTON	02/15/2019
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part338	09/05/2014

NIGHTTIME SLEEP AID 
diphenhydramine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66715-6943
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M)	Diphenhydramine Hydrochloride	25 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	PURPLE	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	602
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66715-6943-0	12 in 1 CARTON	02/15/2019
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part338	02/15/2019

Labeler - Lil' Drug Store Products, Inc (093103646)