ZZZQUIL ALCOHOL FREE NIGHTTIME SLEEP-AID- diphenhydramine hydrochloride solution

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 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

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.

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

Other information

• each 30 mL contains:
  
  sodium 24 mg
• store at controlled room temperature

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

Questions or comments?

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™

ALCOHOL FREE

NIGHTTIME SLEEP-AID

Diphenhydramine HCl

• Non-Habit Forming

Soothing Mango Berry

Not for treating Cold or Flu

12 FL OZ (354 ml)

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

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
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part338	02/03/2015

Labeler - The Procter & Gamble Manufacturing Company (004238200)