DZA Brands, LLC Sleeptime Drug Facts

Healthy Accents Sleeptime by

Drug Labeling and Warnings

Healthy Accents Sleeptime by is a Otc medication manufactured, distributed, or labeled by DZA Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTHY ACCENTS SLEEPTIME- diphenhydramine hcl capsule, liquid filled 
DZA Brands LLC

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.

----------

DZA Brands, LLC Sleeptime Drug Facts

Active ingredient (in each softgel)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

• for the 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
• with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
• with other Nighttime products

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• difficulty in urination due to an 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
• drowsiness will occur
• do not drive a motor vehicle or operate machinery

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.

Overdose warning:Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

• take only one dose per day (24 hours) – see Overdose warning

• adults & children 12 yrs & over:

  2 softgels at bedtime if needed or as directed by a doctor

• children under 12 yrs:

  do not use

Other information

• store at 20-25°C (68-77°F)
• avoid excessive heat above 40°C (104°F)
• protect from light

Inactive ingredients

edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution

Questions or comments?

1-866-322-2439

Package/Label Principal Display Panel

Compare to Vicks® ZzzQuil® Nighttime Sleep-aid active ingredient

sleeptime

nighttime sleep-aid

diphenhydramine HCl 25mg

non-habit forming

not for treating colds or the flu

see warnings

#1 Doctor Recommended Active Ingredient

actual size

NO GLUTEN

12 softgels

HEALTHY ACCENTS SLEEPTIME 
diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55316-052
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, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	PURPLE	Score	no score
Shape	CAPSULE	Size	15mm
Flavor		Imprint Code	052
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55316-052-53	12 in 1 CARTON	05/11/2016	01/01/2019
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 55316-052-62	24 in 1 CARTON	05/11/2016	01/01/2019
2		1 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	05/11/2016	01/01/2019

Labeler - DZA Brands LLC (090322194)

Revised: 12/2019

Document Id: a0e66964-f865-4357-8621-6e8dee306f4b

34390-5

Set id: be1f77f8-dd30-4e7c-96a3-2e93ab9f3e7a

Version: 3

Effective Time: 20191211