HEALTHY ACCENTS SLEEPTIME- diphenhydramine hcl solution 
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.

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DZA Brands, LLC Sleeptime Drug Facts

Active ingredient (in each 30 mL dose cup)

Diphenhydramine HCl 50 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
•
use dose cup

adults & children 12 yrs & over

30 mL at bed time if needed or as directed by a doctor

children under 12 yrs

do not use

Other information

•
each 30 mL dose cup contains: sodium 20 mg
•
store at 20-25˚C (68-77˚F)
•
protect from light. Does not meet USP <671>.

Inactive Ingredients

alcohol, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, poloxamer 407, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate

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 50mg per 30mL

non habit-forming

not for treating colds or the flu

see warnings

Doctor Recommended #1 Active Ingredient

berry flavor – gluten free

12 FL OZ (355mL)

ALCOHOL 10%

Healthy Accents Sleeptime
HEALTHY ACCENTS SLEEPTIME 
diphenhydramine hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-186
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55316-186-40355 mL in 1 BOTTLE; Type 0: Not a Combination Product05/09/201411/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33805/09/201411/30/2019
Labeler - DZA Brands LLC (090322194)

Revised: 11/2019
Document Id: 9d7f5978-dc8c-467e-afca-804a8ed76e90
Set id: 4215462a-37d7-41f1-a70c-9f9effc3de0e
Version: 3
Effective Time: 20191118
 
DZA Brands LLC