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ZzzQuil Nighttime Sleep-Aid by Procter & Gamble Manufacruing Company

Dosage form: liquid
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50mg in 30mL
Labeler: Procter & Gamble Manufacruing Company
NDC Code: 37000-500

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ZzzQuil™
NIGHTTIME SLEEP-AID

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
  • 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 & overOne Dose = 30 mL (2 tablespoons) at bed time if needed or as directed by a doctor

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   NIGHTTIME SLEEP-AID
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-500
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorPURPLEScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:37000-500-06177 mL in 1 BOTTLE, PLASTIC
2NDC:37000-500-12354 mL in 1 BOTTLE, PLASTIC
3NDC:37000-500-242 BOTTLE, PLASTIC in 1 PACKAGE, COMBINATION
3NDC:37000-500-12354 mL in 1 BOTTLE, PLASTIC
4NDC:37000-500-363 BOTTLE, PLASTIC in 1 PACKAGE, COMBINATION
4NDC:37000-500-12354 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33812/08/2011
Labeler - Procter & Gamble Manufacruing Company (004238200)

Revised: 09/2014
 
Procter & Gamble Manufacruing Company

← See all ZzzQuil Nighttime Sleep-Aid brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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