NIGHTTIME SLEEP AID- diphenhydramine hcl liquid

Nighttime Sleep Aid by

Drug Labeling and Warnings

Nighttime Sleep Aid by is a Otc medication manufactured, distributed, or labeled by L.N.K. International, Inc., LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (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 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

Quality
     Plus

NDC: 50844-200-45

Compare to active ingredient in
VICKS® ZzzQuil® Nighttime
Sleep-Aid*

Nighttime
Sleep Aid

Diphenhydramine HCl 50 mg

NIGHTTIME SLEEP-AID

Non-habit forming
Not for treating Cold or Flu

Berry Flavor

6 FL OZ (177 mL) 

ALCOHOL FREE

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     ORG101700245

Distributed by:
LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USA

44-002A

INGREDIENTS AND APPEARANCE

NIGHTTIME SLEEP AID 
diphenhydramine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50844-200
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: 50844-200-45	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/12/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part338	09/12/2016

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

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	MANUFACTURE(50844-200) , PACK(50844-200)