Zzzquil Alcohol Free Nighttime Sleep-Aid (Diphenhydramine Hydrochloride) Solution [The Procter & Gamble Manufacturing Company] -

ZZZQUIL ALCOHOL FREE NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) SOLUTION [THE PROCTER & GAMBLE MANUFACTURING COMPANY]
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NDC	37000-431-06, 37000-431-12, 37000-431-24
Set ID	7b0cc06d-c1bd-415b-953f-6f89adbb2e59
Category	HUMAN OTC DRUG LABEL
Packager	The Procter & Gamble Manufacturing Company
Generic Name
Product Class
Product Number
Application Number	PART338

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SPL UNCLASSIFIED SECTION

Drug Facts
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Active ingredient (in each 30 mL dose cup)

Diphenhydramine HCl 50 mg
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Purpose

Nighttime sleep-aid
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Uses
- for the relief of occasional sleeplessness
- reduces time to fall asleep if you have difficulty falling asleep
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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 a 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.

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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
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Other information
- each 30 mL contains:
  
  sodium 24 mg
- store at controlled room temperature
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Inactive ingredients

citric acid anhydrous, FD&C Blue No. 1, flavor, high fructose corn syrup, polyoxyl 40 stearate, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate
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Questions or comments?

1-877-881-5813
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SPL UNCLASSIFIED SECTION

Dist. by Procter & Gamble,
Cincinnati OH 45202.
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PRINCIPAL DISPLAY PANEL - 354 mL Bottle Label
NEW

From the makers of VICKS ® NyQuil™

ZzzQuil™

ALCOHOL FREE

NIGHTTIME SLEEP-AID

Diphenhydramine HCl
- Non-Habit Forming
Soothing Mango Berry

Not for treating Cold or Flu

12 FL OZ (354 ml)

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INGREDIENTS AND APPEARANCE

ZZZQUIL ALCOHOL FREE NIGHTTIME SLEEP-AID
diphenhydramine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37000-431
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor	MANGO (Berry)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:37000-431-06	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/03/2015
2	NDC:37000-431-24	2 in 1 PACKAGE, COMBINATION	02/03/2015
2	NDC:37000-431-12	354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC:37000-431-12	354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/03/2015