SLEEP AID- diphenhydramine hcl liquid

Sleep Aid by

Drug Labeling and Warnings

Sleep Aid by is a Otc medication manufactured, distributed, or labeled by Harmon Store Inc., LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 (1-800-222-1222) right away.

Directions

• do not take more than directed
• mL = milliliter; TBSP = tablespoon; 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 (2 TBSP) in the dosing cup provided 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 25ºC (77Fº); excursions permitted between 15º-30ºC (59º-86ºF)
• 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

CORE VALUES™

Compare to the active ingredient in Vicks® ZzzQuil® NIGHTTIME SLEEP-AID †

Nightime
Sleep Aid
Diphenhydramine HCl /
Nighttime Sleep Aid

Non-habit forming
Alcohol free

12 FL OZ (355 mL)  berry flavor

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

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

50844      ORG101700202

Distributed by: Liberty Procurement Co. Inc.
650 Liberty Ave., Union, NJ 07083 U.S.A
Satisfaction Guaranteed Or Your Money Back
Visit us at www.facevalues.com

Core Values 44-002A

INGREDIENTS AND APPEARANCE

SLEEP AID 
diphenhydramine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63940-200
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)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

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: 63940-200-02	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/2018
2	NDC: 63940-200-45	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part338	10/01/2018

Labeler - Harmon Store Inc. (804085293)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	MANUFACTURE(63940-200) , PACK(63940-200)