ZZZQUIL NIGHTTIME SLEEP-AID- diphenhydramine hydrochloride liquid

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 30 mL dose cup or 2 tablespoons)

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.

Overdose warning

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
• only use 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 dose (2 tablespoons) contains: sodium 24 mg
• store at controlled room temperature

Inactive ingredients

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

Questions?

1-877-881-5813

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Dist. by Procter & Gamble,
Cincinnati OH 45202.

PRINCIPAL DISPLAY PANEL - 354 ml Bottle Label

NEW From the makers of VICKS ® NyQuil®

ZzzQuil™

NIGHTTIME SLEEP-AID

Diphenhydramine HCl

• Non-Habit Forming
• Warming Berry Flavor

Not for treating Cold or Flu

See Warnings

Alcohol 10%

12 FL OZ (354 ml)

INGREDIENTS AND APPEARANCE

ZZZQUIL  NIGHTTIME SLEEP-AID
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-500
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALCOHOL (UNII: 3K9958V90M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
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)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

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: 37000-500-06	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/08/2011
2	NDC: 37000-500-12	354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/08/2011
3	NDC: 37000-500-24	2 in 1 PACKAGE, COMBINATION	12/08/2011
3	NDC: 37000-500-12	354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC: 37000-500-36	3 in 1 PACKAGE, COMBINATION	12/08/2011
4	NDC: 37000-500-12	354 mL in 1 BOTTLE, PLASTIC; 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)