Zzzquil Nighttime Sleep-Aid (Diphenhydramine Hydrochloride) Capsule, Gelatin Coated [The Procter & Gamble Manufacturing Company] -

ZZZQUIL NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, GELATIN COATED [THE PROCTER & GAMBLE MANUFACTURING COMPANY]
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NDC	37000-501-12, 37000-501-24, 37000-501-48, 37000-501-72
Set ID	ad4babdb-d98d-420e-b8b0-9a5368c89a44
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 ingredients (in each liquicap)

Diphenhydramine HCl 25 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 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) - see Overdose warning
adults & children 12 yrs & over

One dose = TWO 25 mg LiquiCaps (50 mg) at bed time if needed or as directed by a doctor

children under 12 yrs

do not use
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Other information
- store at 20-25° C (68-77° F)
- avoid excessive heat above 40° C (104° F)
- protect from light.
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Inactive ingredients

FD&C Blue No. 1, FD&C Red No. 40, gelatin, glycerin, pharmaceutical ink*, polyethylene glycol, purified water, sorbitol sorbitan solution.
*May contain this ingredient.
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Questions?

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 - 12 Capsule Carton

NEW From the makers of VICKS ® NyQuil ®

ZzzQuil™

NIGHTTIME SLEEP-AID

Diphenhydramine HCl

Non-Habit Forming

See Warnings

Not for treating Cold or Flu

12 LiquiCaps

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INGREDIENTS AND APPEARANCE

ZZZQUIL NIGHTTIME SLEEP-AID
diphenhydramine hydrochloride capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37000-501
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 2

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	purple	Score	no score
Shape	CAPSULE	Size	15mm
Flavor		Imprint Code	Zzz
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:37000-501-12	6 in 1 CARTON	12/08/2011
1		2 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:37000-501-24	12 in 1 CARTON	12/08/2011
2		2 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:37000-501-48	24 in 1 CARTON	12/08/2011
3		2 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC:37000-501-72	36 in 1 CARTON	12/08/2011
4		2 in 1 BLISTER PACK; Type 0: Not a Combination Product