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ZzzQuil

Procter & Gamble Manufacruing Company

ZzzQuil™ NIGHTTIME SLEEP-AID


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients (in each 30 mL dose cup or 2 tablespoons)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

ZzzQuil 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
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products
  • Do not use with NyQuil

Ask a doctor before use if you have

  • a breathing problem such as asthma, emphysema, or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • heart disease

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid

When using this product

  • avoid alcoholic beverages and other drugs that cause drowsiness
  • drowsiness will occur
  • be careful when driving a motor vehicle or operating machinery

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

Taking more than directed can cause serious health problems. 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
  • use dose cup or tablespoon
adults & children 12 yrs & over One Dose = 30 mL (2 tablespoons) at bed time if needed or as directed by a doctor

ZzzQuil Other information

  • each 30 mL dose (2 tablespoons) contains: sodium 23 mg
  • store at room temperature
  • protect from light. Does not meet USP <671>.

Inactive ingredients

citric acid, ethanol, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, polyoxyl 40 stearate, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate dihydrate

Questions?

1-877-881-5813

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)

ZzzQuil

ZzzQuil

DIPHENHYDRAMINE HYDROCHLORIDE LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:37000-500
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 50 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
ALCOHOL
FD&C BLUE NO. 1
FD&C RED NO. 40
HIGH FRUCTOSE CORN SYRUP
POLYOXYL 40 STEARATE
propylene glycol
water
saccharin sodium
SODIUM BENZOATE
TRISODIUM CITRATE DIHYDRATE

Product Characteristics

Color
PURPLE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:37000-500-06 177 in 1 BOTTLE, PLASTIC
2 NDC:37000-500-12 354 in 1 BOTTLE, PLASTIC
3 NDC:37000-500-12 354 in 1 BOTTLE, PLASTIC
4 NDC:37000-500-12 354 in 1 BOTTLE, PLASTIC
5 NDC:37000-500-36 3 in 1 PACKAGE, COMBINATION

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part338 2011-12-08


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Be sure to consult your doctor before taking any medication!
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