TOPCARE ZZZ SLEEP- diphenhydramine hydrochloride solution 
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 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?

1-888-423-0139

Package/Label Principal Display Panel

NIGHTTIME SLEEP-AID

ZZZ Sleep®

DIPHENHYDRAMINE HCl

50 mg PER 30 mL

Non-habit forming

BERRY FLAVOR

COMPARE TO VICKS® ZzzQuil® active ingredient

ALCOHOL 10%

Not for treating Cold or Flu

See Warnings

6 FL OZ (177 mL)

Topcare ZZZ Sleep Image 1
Topcare ZZZ Sleep Image 2
TOPCARE ZZZ SLEEP 
diphenhydramine hcl solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-200
Route of Administration ORAL DEA Schedule     
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 (clear) 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
2 NDC:36800-200-40 355 mL in 1 BOTTLE
3 NDC:36800-200-34 236 mL in 1 BOTTLE
4 NDC:36800-200-50 2 in 1 PACKAGE
4 355 mL in 1 BOTTLE
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)
Registrant - L. Perrigo Company (006013346)
Establishment
Name Address ID/FEI Business Operations
L. Perrigo Company 006013346 MANUFACTURE(36800-200)

Revised: 12/2014
Document Id: 0d72d72a-3ed7-4ef6-ae50-f1f9d4168088
Set id: 27225d04-6deb-436b-89ea-9842c487292e
Version: 3
Effective Time: 20141202
 
Topco Associates LLC