TOPCARE ZZZ SLEEP- diphenhydramine hcl capsule, liquid filled

Topcare ZZZ Sleep by

Drug Labeling and Warnings

Topcare ZZZ Sleep by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

COMPARE TO VICKS® ZZZQUIL® ACTIVE INGREDIENT

NIGHTTIME

ZZZ Sleep®

DIPHENHYDRAMINE HCl 25 mg

NIGHTTIME SLEEP-AID

OUR PHARMACISTS RECOMMEND

Non-Habit Forming

Not for Treating Cold or Flu

See Warnings

12 SOFTGELS

actual size

INGREDIENTS AND APPEARANCE

TOPCARE ZZZ SLEEP 
diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-507
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)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-507-53	6 in 1 CARTON	01/28/2014
1		2 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 36800-507-67	24 in 1 CARTON	01/28/2014
2		2 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 36800-507-62	12 in 1 CARTON	01/28/2014
3		2 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	01/28/2014

Labeler - Topco Associates LLC (006935977)