NIGHTTIME SLEEP AID- diphenhydramine hcl solution

Nighttime Sleep Aid by

Drug Labeling and Warnings

Nighttime Sleep Aid by is a Otc medication manufactured, distributed, or labeled by TOPCO ASSOCIATES LLC, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 30 mL)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses

• for 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
• difficulty in urination due to enlargement of the 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 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.

Directions

• do not take more than directed
• mL = milliliter
• only use the dose cup provided
• take only one dose per day (24 hours)
• adults and children 12 years and over: take 30 mL at bedtime if needed or as directed by a doctor
• children under 12 years: do not use

Other information

• each 30 mL contains: sodium 11 mg
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• use by expiration date on package

Inactive ingredients

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, high fructose corn syrup, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, sucrose, xanthan gum

Questions or comments?

1-888-423-0139

Principal Display Panel 

TopCare®
health

NDC: 76162-200-45

NIGHTTIME

*COMPARE TO THE
ACTIVE INGREDIENT
IN VICKS® ZzzQUIL®
NIGHTTIME SLEEP-AID

Nighttime
Sleep Aid
DIPHENHYDRAMINE HCl 50 mg
per 30 mL
NIGHTTIME SLEEP-AID

Non-Habit Forming
Not for Colds or for Pain

Ages 12 Years
and Over

6 FL OZ (177 mL)

BERRY
FLAVOR

TAMPER EVIDENT: DO NOT
USE IF PRINTED NECK WRAP
IS BROKEN OR MISSING

*This product is not manufactured or distributed by The
Procter & Gamble Company, owner of the registered
trademark VICKS® ZzzQuil® NIGHTTIME SLEEP-AID.

50844 ORG022600245

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ITASCA, IL 60143 ©TOPCO LNKA0326
QUESTIONS? 1-888-423-0139
topcare@topco.com      www.topcarebrand.com
Visit here for more information: http://topbrnds.com/CTNTSY

TopCare 44-002A

INGREDIENTS AND APPEARANCE

NIGHTTIME SLEEP AID 
diphenhydramine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76162-200
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	purple	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76162-200-45	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/11/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M010	01/11/2023

Labeler - TOPCO ASSOCIATES LLC (006935977)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	manufacture(76162-200) , pack(76162-200)