TOPCARE ZZZ SLEEP- diphenhydramine hcl solution

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 30 mL)

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

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• 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 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)
• only use the dose cup provided

• 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 contains: sodium 20 mg
• store at 20-25°C (68-77°F)

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?

1-888-423-0139

Package/Label Principal Display Panel

NIGHTTIME ZZZ Sleep®

COMPARE TO VICKS® ZZZQUIL® ACTIVE INGREDIENT

OUR PHARMACISTS RECOMMEND

DIPHENHYDRAMINE HCl 50 mg per 30 mL

NIGHTTIME SLEEP-AID

Non-Habit Forming

Not for Treating Cold or Flu

Alcohol 10%

6 FL OZ (177 mL)

BERRY FLAVOR

INGREDIENTS AND APPEARANCE

TOPCARE ZZZ SLEEP 
diphenhydramine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-200
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	PURPLE	Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-200-30	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/23/2013
2	NDC: 36800-200-40	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/20/2013
3	NDC: 36800-200-34	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/19/2013
4	NDC: 36800-200-50	2 in 1 PACKAGE	08/20/2013
4		355 mL in 1 BOTTLE; 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	08/20/2013

Labeler - Topco Associates LLC (006935977)