NIGHTTIME SLEEP AID- diphenhydramine hcl capsule, liquid filled

Nighttime Sleep Aid by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient (in each liquid-filled capsule)

Diphenhydramine HCl 25 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

• glaucoma
• a breathing problem such as emphysema or chronic bronchitis
  
• 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
  
• take only one dose per day (24 hours)
  
• adults and children 12 years and over: take 2 capsules at bedtime if needed or as directed by a doctor
  
• children under 12 years: do not use
  

Other information

• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
• protect from light
• see end flap for expiration date and lot number
  
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  
• avoid excessive heat above 40°C (104°F) and high humidity
  

Inactive ingredients

edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, lecithin, mineral oil, polyethylene glycol, purified water, sorbitol

Questions or comments?

1-800-426-9391

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      Care

Quality Guaranteed

COMPARE TO
VICKS® ZzzQuil™ NIGHTTIME
SLEEP-AID LiquiCaps®
active ingredient*

NDC: 21130-654-08

Nighttime Sleep Aid

Diphenhydramine HCl 25 mg
Nighttime Sleep Aid

Non-habit forming
Not for treating cold or flu

actual size

24 SOFT LIQUID-FILLED CAPSULES

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by
Procter & Gamble, distributors of VICKS® ZzzQuil™
NIGHTTIME SLEEP-AID LiquiCaps®.

50844    ORG071665408

Product of China

Packaged and Quality Assured in the USA

DISTRIBUTED BY
BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
1-888-723-3929
www.betterlivingbrandsLLC.com

Signature Care 44-654

INGREDIENTS AND APPEARANCE

NIGHTTIME SLEEP AID 
diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-654
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 (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MINERAL OIL (UNII: T5L8T28FGP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	PURPLE (clear)	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	654
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-654-08	2 in 1 CARTON	05/24/2019
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 21130-654-22	4 in 1 CARTON	05/24/2019
2		12 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	05/24/2019

Labeler - Better Living Brands, LLC (009137209)

Establishment
Name	Address	ID/FEI	Business Operations
Humanwell Puracap Pharmaceuticals (Wuhan) Co., Ltd		421293287	API MANUFACTURE(21130-654)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(21130-654)