NIGHTTIME SLEEP AID- diphenhydramine hcl solution
L.N.K. International, 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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Sound Body 44-002A

Active ingredient (in each 30 mL dose cup)

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 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.

Directions

do not take more than directed
mL = milliliter; FL OZ = fluid ounce
use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
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 dose cup contains: sodium 17 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?

1-800-426-9391

Principal display panel

SOUNDBODY™

*Compare to the active ingredient in VICKS® ZzzQuil® NIGHTTIME SLEEP-AID

NDC 50844-102-00

Alcohol Free

Nighttime
Sleep-Aid

Diphenhydramine HCl 50 mg

NIGHTTIME SLEEP-AID

Non-habit Forming
Not for treating Pain, Cold or Flu

Berry Flavor

12 FL OZ (355 mL)

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 REV1120A00202

Manufactured for Big Lots Stores, Inc.
by LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788 USA
V#733000 ITEM#022700202

Sound Body 44-002A

NIGHTTIME SLEEP AID
diphenhydramine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50844-102
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50844-102-00	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/04/2020
2	NDC:50844-102-02	2 in 1 PACKAGE	03/04/2020
2		355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part338	03/04/2020

Labeler - L.N.K. International, Inc. (038154464)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	manufacture(50844-102) , pack(50844-102)

Revised: 3/2022

Document Id: d134628b-3c68-47cd-9114-0755cc3f1764

Set id: 0afa2011-11fd-4a76-a7b8-8e91edb3f50f

Version: 6

Effective Time: 20220304

L.N.K. International, Inc.