ZZZQUIL NIGHTTIME SLEEP-AID- diphenhydramine hydrochloride capsule, gelatin coated

ZzzQuil by

Drug Labeling and Warnings

ZzzQuil by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredients (in each liquicap)

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 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.

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

Other information

• store at 20-25° C (68-77° F)
• avoid excessive heat above 40° C (104° F)
• protect from light.

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.

Questions?

1-877-881-5813

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Dist. by Procter & Gamble, Cincinnati OH 45202.

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

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg  in 2

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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
5	NDC: 37000-501-96	2 in 1 CELLO PACK	01/01/2020
5		24 in 1 CARTON
5		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	12/08/2011

Labeler - The Procter & Gamble Manufacturing Company (004238200)