TOPCARE ZZZ SLEEP- diphenhydramine hcl capsule, liquid filled 
Topco Associates 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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Topco Associates LLC. ZZZ® Sleep 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

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

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.

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)
 
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 40oC (104oF)
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?

1-888-423-0139

Package/Label Principal Display Panel

TopCare® health

COMPARE TO VICKS® ZZZQUIL® ACTIVE INGREDIENT

NIGHTTIME

ZZZ Sleep®

DIPHENHYDRAMINE HCl 25 mg

NIGHTTIME SLEEP-AID

• Non-Habit Forming

• Not for Treating Cold or Flu

See Warnings

12 SOFTGELS

actual size

052-88-zzz-sleep
TOPCARE ZZZ SLEEP 
diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-507
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
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)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColorPURPLEScoreno score
ShapeOVALSize15mm
FlavorImprint Code 052
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-507-536 in 1 CARTON01/28/2014
12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:36800-507-6724 in 1 CARTON01/28/2014
22 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:36800-507-6212 in 1 CARTON01/28/2014
32 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33801/28/2014
Labeler - Topco Associates LLC (006935977)

Revised: 1/2023
Document Id: 9faf3e3c-a262-4c34-b613-998bddded756
Set id: 4304584b-df01-4a77-96e2-a2b96184da54
Version: 9
Effective Time: 20230116
 
Topco Associates LLC